Trial Outcomes & Findings for Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer (NCT NCT02101788)

NCT ID: NCT02101788

Last Updated: 2025-11-13

Results Overview

Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the PFS endpoint definition.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 260 participants
• Primary outcome timeframe: Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B
• Results posted on: 2025-11-13

Participant Flow

A total of 260 patients enrolled before accrual closed on 04/10/2018.

Participant milestones

Measure	Arm A - Control Arm Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
Overall Study STARTED	130	130
Overall Study Crossover From Arm A to Arm B	88	0
Overall Study COMPLETED	120	116
Overall Study NOT COMPLETED	10	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

Baseline characteristics by cohort

Measure	Arm A - Control Arm n=130 Participants Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=130 Participants Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days	Total n=260 Participants Total of all reporting groups
Age, Continuous	53.89 years STANDARD_DEVIATION 14.03 • n=10 Participants	53.57 years STANDARD_DEVIATION 14.13 • n=10 Participants	53.7 years STANDARD_DEVIATION 14.1 • n=20 Participants
Age, Customized 20-29 years	9 Participants n=10 Participants	10 Participants n=10 Participants	19 Participants n=20 Participants
Age, Customized 30-39 years	18 Participants n=10 Participants	16 Participants n=10 Participants	34 Participants n=20 Participants
Age, Customized 40-49 years	21 Participants n=10 Participants	22 Participants n=10 Participants	43 Participants n=20 Participants
Age, Customized 50-59 years	28 Participants n=10 Participants	35 Participants n=10 Participants	63 Participants n=20 Participants
Age, Customized 60-69 years	39 Participants n=10 Participants	33 Participants n=10 Participants	72 Participants n=20 Participants
Age, Customized >= 70 years	15 Participants n=10 Participants	14 Participants n=10 Participants	29 Participants n=20 Participants
Sex: Female, Male Female	130 Participants n=10 Participants	130 Participants n=10 Participants	260 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=10 Participants	8 Participants n=10 Participants	15 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=10 Participants	118 Participants n=10 Participants	236 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=10 Participants	4 Participants n=10 Participants	9 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	2 Participants n=10 Participants	2 Participants n=10 Participants	4 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=10 Participants	2 Participants n=10 Participants	4 Participants n=20 Participants
Race (NIH/OMB) Black or African American	5 Participants n=10 Participants	4 Participants n=10 Participants	9 Participants n=20 Participants
Race (NIH/OMB) White	114 Participants n=10 Participants	115 Participants n=10 Participants	229 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=10 Participants	7 Participants n=10 Participants	14 Participants n=20 Participants
Region of Enrollment United States	102 participants n=10 Participants	103 participants n=10 Participants	205 participants n=20 Participants
Region of Enrollment United Kingdom	28 participants n=10 Participants	27 participants n=10 Participants	55 participants n=20 Participants
Number of Prior Treatment Regimens 1 Prior Treatment Regimens	30 Participants n=10 Participants	29 Participants n=10 Participants	59 Participants n=20 Participants
Number of Prior Treatment Regimens 2 Prior Treatment Regimens	37 Participants n=10 Participants	39 Participants n=10 Participants	76 Participants n=20 Participants
Number of Prior Treatment Regimens 3 or More Prior Treatment Regimens	63 Participants n=10 Participants	62 Participants n=10 Participants	125 Participants n=20 Participants

PRIMARY outcome

Timeframe: Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B

Population: All randomized patients

Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the PFS endpoint definition.

Outcome measures

Measure	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing	Arm A - Control Arm n=130 Participants Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=130 Participants Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
Progression-free Survival (PFS)	—	—	7.2 months Interval 5.6 to 9.9	13.0 months Interval 9.9 to 15.0

SECONDARY outcome

Timeframe: During treatment period and up to 100 days after stopping the study treatment

Population: Treated with randomized therapy

Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy. Excludes AEs observed among control patients treated with trametinib after crossover.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the AE endpoint definition.

Outcome measures

Measure	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing	Arm A - Control Arm n=127 Participants Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=127 Participants Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
Incidence of Adverse Events (AEs) Diarrhea	—	—	4 participants	13 participants
Incidence of Adverse Events (AEs) Fatigue	—	—	5 participants	10 participants
Incidence of Adverse Events (AEs) Hypertension	—	—	6 participants	15 participants
Incidence of Adverse Events (AEs) Nausea	—	—	14 participants	12 participants
Incidence of Adverse Events (AEs) Neutrophil count decreased	—	—	1 participants	8 participants
Incidence of Adverse Events (AEs) Rash maculo-papular	—	—	0 participants	9 participants
Incidence of Adverse Events (AEs) Small Intestinal Obstruction	—	—	9 participants	16 participants
Incidence of Adverse Events (AEs) Vomiting	—	—	10 participants	9 participants
Incidence of Adverse Events (AEs) Abdominal pain	—	—	22 participants	7 participants
Incidence of Adverse Events (AEs) Anemia	—	—	12 participants	16 participants

SECONDARY outcome

Timeframe: Time from study entry to time of death or date of last contact, an average of 29 months for arm A and 37 months for arm B

Population: All randomized patients

Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Patients with disease progression on the Control arm were allowed to cross over to the trametinib arm. Per the protocol, the intent-to-treat OS analysis was not adjusted for crossover.

Outcome measures

Measure	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing	Arm A - Control Arm n=130 Participants Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=130 Participants Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
Overall Survival	—	—	29.2 Months Interval 23.5 to 51.6	37.0 Months Interval 30.3 to insufficient number of participants with events

SECONDARY outcome

Timeframe: Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B

Population: Randomized patients

The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.

Outcome measures

Measure	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing	Arm A - Control Arm n=130 Participants Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=130 Participants Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
Objective Tumor Response Rate (Complete Response and Partial Response)	—	—	8 participants	34 participants

SECONDARY outcome

Timeframe: 1. baseline (prior to cycle 1), 12 weeks (prior to cycle 4), 24 weeks (4 weeks post cycle 6), 36 weeks post cycle 1, 52 weeks post cycle 1.

Population: Patients who provided baseline and ≥ 1 follow-up assessment

Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). . The FACT-O TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-O TOI items provide valid answers and all of the component subscales have valid scores. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL. Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the quality of life endpoint definition

Outcome measures

Measure	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing	Arm A - Control Arm n=98 Participants Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=100 Participants Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
Patients Reported Acute Quality of Life Baseline	—	—	74.5 score on a scale Standard Deviation 16.6	74.5 score on a scale Standard Deviation 13.7
Patients Reported Acute Quality of Life 12 Weeks	—	—	74.2 score on a scale Standard Deviation 16.0	70.6 score on a scale Standard Deviation 13.5
Patients Reported Acute Quality of Life 24 Weeks	—	—	70.2 score on a scale Standard Deviation 15.5	73.0 score on a scale Standard Deviation 12.8
Patients Reported Acute Quality of Life 36 Weeks	—	—	69.3 score on a scale Standard Deviation 18.6	72.6 score on a scale Standard Deviation 12.8
Patients Reported Acute Quality of Life 52 Weeks	—	—	72.1 score on a scale Standard Deviation 16.9	73.3 score on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: Patients that provided baseline and ≥ 1 follow-up assessment

Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms

Outcome measures

Measure	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC) KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing	Arm A - Control Arm n=98 Participants Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=100 Participants Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
Patient Reported Acute Peripheral Neuropathy Symptoms Baseline	—	—	13.2 score on a scale Standard Deviation 3.5	12.8 score on a scale Standard Deviation 3.8
Patient Reported Acute Peripheral Neuropathy Symptoms 12 Weeks	—	—	12.5 score on a scale Standard Deviation 4.0	12.6 score on a scale Standard Deviation 4.2
Patient Reported Acute Peripheral Neuropathy Symptoms 24 Weeks	—	—	12.4 score on a scale Standard Deviation 4.0	12.1 score on a scale Standard Deviation 4.2
Patient Reported Acute Peripheral Neuropathy Symptoms 36 Weeks	—	—	12.3 score on a scale Standard Deviation 3.8	12.6 score on a scale Standard Deviation 3.9
Patient Reported Acute Peripheral Neuropathy Symptoms 52 Weeks	—	—	12.8 score on a scale Standard Deviation 3.2	12.4 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: Time from study entry to time of progression or death, an average of 7 months for SOC and 13 months for the treatment (Trametinib) arm.

Population: Patients with sufficient tissue for analysis

Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. RECIST v1.1 defines progression as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Outcome measures

Measure	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib) n=48 Participants KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing	KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC) n=42 Participants KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing	Arm A - Control Arm n=22 Participants Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=22 Participants Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
Progression Free Survival	7.3 Months Interval 5.6 to 12.7	6.3 Months Interval 3.7 to 9.9	13.2 Months Interval 9.4 to 20.8	11.4 Months Interval 3.7 to 13.3

SECONDARY outcome

Timeframe: Baseline

Will be quantified using the H-score derived from the immunohistochemistry analysis of patient tumor tissue and is expected to present as a continuous measure. will consider the prognostic and predictive abilities of pERK relative to objective response rate (ORR) or PFS. Analysis of the dichotomous markers will be supported by Kaplan Meier plots, and forest plots of the odds-ratio and hazard ratio estimates. Duration of response will be depicted using swimmer plots, with median duration estimated using Kaplan Meier methods. The multivariable models will include covariate adjustment for geographic region, performance status and number of prior regimens, presented using effect coding. The adjusted hazard- and odds- ratio estimates from the multivariable models will be supported by nominal p-values and 2-sided, 95% confidence intervals. Confidence intervals will be interpreted as the plausible range of values for the true (unobserved) ratio that is supported by the data.

Outcome measures

Outcome data not reported

Adverse Events

Arm A - Control Arm

Serious events: 43 serious events

Other events: 124 other events

Deaths: 60 deaths

Arm B - Experimental Arm

Serious events: 45 serious events

Other events: 127 other events

Deaths: 51 deaths

Crossover From Control to Experimental Arm

Serious events: 25 serious events

Other events: 88 other events

Deaths: 3 deaths

Serious adverse events

Measure	Arm A - Control Arm n=127 participants at risk Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=127 participants at risk Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days	Crossover From Control to Experimental Arm n=88 participants at risk Patients randomized to the control arm who crossed over to the experimental arm after disease progression.
Blood and lymphatic system disorders Anemia	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Eye Disorders - Other	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Retinal Vascular Disorder	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Colonic Obstruction	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.7% 5/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Colonic Stenosis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Colonic Perforation	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Diarrhea	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Vomiting	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Small Intestinal Obstruction	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Abdominal Pain	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Mucositis Oral	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Gastrointestinal Disorders - Other	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Nausea	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Ascites	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Jejunal Obstruction	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Flu Like Symptoms	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Non-Cardiac Chest Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Edema Limbs	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Death Nos	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Hepatobiliary disorders Cholecystitis	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Infections And Infestations - Other	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Upper Respiratory Infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Soft Tissue Infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Sepsis	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Lung Infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Kidney Infection	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Device Related Infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Urinary Tract Infection	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Intestinal Stoma Obstruction	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Ejection Fraction Decreased	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Neutrophil Count Decreased	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Alkaline Phosphatase Increased	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Alanine Aminotransferase Increased	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hyponatremia	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Dehydration	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Anorexia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Renal And Urinary Disorders - Other	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Urinary Tract Obstruction	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Hematuria	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Acute Kidney Injury	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Vaginal Hemorrhage	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Hemorrhage	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Thromboembolic Event	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Hypotension	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Hypertension	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Cardiac Arrest	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Obstruction Gastric	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Ileus	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Skin Infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Delirium	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Urinary Retention	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.

Other adverse events

Measure	Arm A - Control Arm n=127 participants at risk Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days	Arm B - Experimental Arm n=127 participants at risk Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days	Crossover From Control to Experimental Arm n=88 participants at risk Patients randomized to the control arm who crossed over to the experimental arm after disease progression.
Cardiac disorders Atrial Fibrillation	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Ventricular Tachycardia	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Blood and lymphatic system disorders Thrombotic Thrombocytopenic Purpura	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Blood and lymphatic system disorders Lymph Node Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Blood and lymphatic system disorders Anemia	42.5% 54/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	52.0% 66/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	58.0% 51/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Conduction Disorder	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Sinus Bradycardia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Palpitations	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Left Ventricular Systolic Dysfunction	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Acute Coronary Syndrome	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Pulmonary Valve Disease	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Tricuspid Valve Disease	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Atrioventricular Block First Degree	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Cardiac Disorders - Other	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Pericardial Effusion	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Sinus Tachycardia	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.0% 7/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Mitral Valve Disease	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Ear and labyrinth disorders Middle Ear Inflammation	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Ear and labyrinth disorders Vertigo	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Ear and labyrinth disorders Tinnitus	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Ear and labyrinth disorders Hearing Impaired	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Ear and labyrinth disorders Ear Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Endocrine disorders Hypothyroidism	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Endocrine disorders Hyperparathyroidism	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Endocrine disorders Hyperthyroidism	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Eye Disorders - Other	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Watering Eyes	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Keratitis	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Eye Pain	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Cataract	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Photophobia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Conjunctivitis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Retinal Tear	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Retinopathy	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Corneal Ulcer	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Retinal Vascular Disorder	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Blurred Vision	9.4% 12/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	25.2% 32/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	14.8% 13/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Dry Eye	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	10.2% 13/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	12.5% 11/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Retinal Detachment	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Floaters	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Eyelid Function Disorder	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Dysphagia	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.0% 7/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Dyspepsia	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	10.2% 13/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.7% 5/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Dry Mouth	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	15.0% 19/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	25.0% 22/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Colonic Obstruction	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.0% 7/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Colonic Stenosis	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Colonic Perforation	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Colitis	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Colonic Hemorrhage	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Constipation	38.6% 49/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	42.5% 54/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	35.2% 31/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Diarrhea	33.9% 43/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	72.4% 92/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	60.2% 53/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Cheilitis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Vomiting	34.6% 44/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	45.7% 58/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	37.5% 33/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Bloating	16.5% 21/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	16.5% 21/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	20.5% 18/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Small Intestinal Perforation	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Stomach Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Small Intestinal Obstruction	7.1% 9/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.8% 15/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	10.2% 9/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Abdominal Pain	47.2% 60/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	44.1% 56/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	54.5% 48/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Rectal Hemorrhage	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Oral Dysesthesia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Mucositis Oral	18.1% 23/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	36.2% 46/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	27.3% 24/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Oral Hemorrhage	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Ileus	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Gastrointestinal Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Oral Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Abdominal Distension	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.7% 5/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Nausea	51.2% 65/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	60.6% 77/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	54.5% 48/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Gastroparesis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Gastroesophageal Reflux Disease	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.4% 10/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Rectal Pain	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Gastric Fistula	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Fecal Incontinence	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Hemorrhoidal Hemorrhage	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Hemorrhoids	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Ascites	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Toothache	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Jejunal Obstruction	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Anal Fistula	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Dental Caries	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Flatulence	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Gastritis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Pain	10.2% 13/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	19.7% 25/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	14.8% 13/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Neck Edema	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Malaise	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Localized Edema	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.0% 7/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Irritability	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Flu Like Symptoms	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Edema Trunk	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Non-Cardiac Chest Pain	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Edema Limbs	11.8% 15/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	48.0% 61/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	40.9% 36/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Edema Face	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.7% 5/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Fatigue	59.1% 75/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	72.4% 92/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	67.0% 59/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Fever	10.2% 13/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	17.3% 22/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	13.6% 12/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Chills	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.8% 15/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.4% 10/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Hepatobiliary disorders Portal Vein Thrombosis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Hepatobiliary disorders Cholecystitis	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Immune system disorders Allergic Reaction	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Infections And Infestations - Other	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Wound Infection	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Upper Respiratory Infection	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.0% 14/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Tooth Infection	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Vulval Infection	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Soft Tissue Infection	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Skin Infection	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	15.0% 19/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.4% 10/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Sinusitis	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Sepsis	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Rhinitis Infective	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Rash Pustular	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Pharyngitis	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Otitis Media	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Papulopustular Rash	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	9.4% 12/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Nail Infection	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Mucosal Infection	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Lung Infection	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	10.2% 9/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Laryngitis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Kidney Infection	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Paronychia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	10.2% 9/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Eye Infection	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Device Related Infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Small Intestine Infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Gum Infection	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Vaginal Infection	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Urinary Tract Infection	14.2% 18/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	22.8% 29/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	15.9% 14/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Bronchial Infection	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Enterocolitis Infectious	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Lip Infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Anorectal Infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Vascular Access Complication	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Urostomy Obstruction	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Seroma	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Postoperative Hemorrhage	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Intestinal Stoma Site Bleeding	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Intestinal Stoma Obstruction	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Fracture	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Fall	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Wound Complication	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Dermatitis Radiation	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Burn	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Intestinal Stoma Leak	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Bruising	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Weight Loss	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	10.2% 9/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Weight Gain	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Platelet Count Decreased	10.2% 13/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	17.3% 22/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	9.1% 8/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Lymphocyte Count Increased	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Lymphocyte Count Decreased	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Lipase Increased	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Inr Increased	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Ggt Increased	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Electrocardiogram Qt Corrected Interval Prolonged	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Ejection Fraction Decreased	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.0% 7/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Creatinine Increased	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	19.7% 25/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	17.0% 15/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Cholesterol High	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Neutrophil Count Decreased	15.0% 19/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	16.5% 21/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	13.6% 12/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Cardiac Troponin I Increased	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Cpk Increased	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Cd4 Lymphocytes Decreased	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Blood Bilirubin Increased	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations White Blood Cell Decreased	16.5% 21/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	22.0% 28/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	19.3% 17/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Aspartate Aminotransferase Increased	11.8% 15/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	37.0% 47/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	30.7% 27/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Alkaline Phosphatase Increased	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	24.4% 31/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	17.0% 15/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Alanine Aminotransferase Increased	10.2% 13/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	21.3% 27/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	17.0% 15/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Investigations Activated Partial Thromboplastin Time Prolonged	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Obesity	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypophosphatemia	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	7.1% 9/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hyponatremia	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	12.6% 16/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	10.2% 9/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypomagnesemia	22.8% 29/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	32.3% 41/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	31.8% 28/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypokalemia	12.6% 16/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	21.3% 27/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	12.5% 11/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypoglycemia	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypocalcemia	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	19.7% 25/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	17.0% 15/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypoalbuminemia	12.6% 16/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	33.1% 42/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	27.3% 24/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypernatremia	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypermagnesemia	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hyperkalemia	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.7% 5/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hyperglycemia	19.7% 25/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	25.2% 32/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	18.2% 16/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Hypercalcemia	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Dehydration	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.0% 7/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Metabolism and nutrition disorders Anorexia	18.9% 24/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	26.0% 33/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	39.8% 35/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Pain In Extremity	7.1% 9/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	7.1% 9/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Neck Pain	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Myalgia	11.8% 15/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	12.6% 16/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.4% 10/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Muscle Weakness Trunk	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Joint Range Of Motion Decreased	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Joint Effusion	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Flank Pain	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Chest Wall Pain	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Bone Pain	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Back Pain	18.9% 24/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	18.9% 24/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	22.7% 20/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Arthritis	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Arthralgia	16.5% 21/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	17.0% 15/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder - O	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Tremor	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Stroke	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Presyncope	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Peripheral Sensory Neuropathy	22.0% 28/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	28.3% 36/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	19.3% 17/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Peripheral Motor Neuropathy	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Paresthesia	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.7% 5/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Memory Impairment	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Lethargy	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Headache	18.9% 24/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	22.0% 28/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	22.7% 20/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Dysphasia	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Dysgeusia	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	9.1% 8/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Sinus Pain	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Dysarthria	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Syncope	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Dizziness	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	17.3% 22/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	12.5% 11/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Concentration Impairment	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Nervous system disorders Cognitive Disturbance	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Personality Change	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Restlessness	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Libido Decreased	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Insomnia	18.9% 24/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	12.6% 16/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	19.3% 17/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Depression	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	20.5% 26/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.4% 10/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Confusion	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Anxiety	9.4% 12/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.8% 15/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	12.5% 11/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Agitation	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Urine Discoloration	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Urinary Urgency	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Urinary Tract Obstruction	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Urinary Retention	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.7% 5/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Urinary Incontinence	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.7% 5/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Urinary Tract Pain	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Urinary Frequency	7.1% 9/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	7.9% 10/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	10.2% 9/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Proteinuria	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Hematuria	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	15.7% 20/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Cystitis Noninfective	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Chronic Kidney Disease	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Bladder Spasm	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Renal and urinary disorders Acute Kidney Injury	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Vaginal Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Vaginal Hemorrhage	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Vaginal Fistula	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Vaginal Dryness	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Uterine Pain	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Pelvic Pain	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Menorrhagia	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Vaginal Discharge	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Vaginal Inflammation	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Dyspareunia	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Breast Pain	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Voice Alteration	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Sore Throat	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	9.1% 8/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Sneezing	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Sinus Disorder	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Pharyngeal Mucositis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Productive Cough	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Laryngeal Inflammation	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Sleep Apnea	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Hiccups	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.8% 15/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	13.6% 12/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	21.3% 27/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	34.6% 44/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	29.5% 26/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Cough	16.5% 21/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	23.6% 30/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	21.6% 19/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Hemorrhage	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.8% 6/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Skin Ulceration	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	5.7% 5/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Skin Induration	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Scalp Pain	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Rash Acneiform	10.2% 13/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	63.0% 80/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	56.8% 50/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Purpura	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Pruritus	5.5% 7/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	19.7% 25/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	20.5% 18/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Periorbital Edema	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	16.5% 21/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	6.3% 8/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.4% 10/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Pain Of Skin	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	22.0% 28/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	42.5% 54/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	34.1% 30/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Nail Ridging	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Nail Loss	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Nail Discoloration	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Hirsutism	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.1% 4/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Erythema Multiforme	0.79% 1/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Dry Skin	13.4% 17/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	44.1% 56/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	45.5% 40/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Bullous Dermatitis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Skin and subcutaneous tissue disorders Alopecia	12.6% 16/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	22.0% 28/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	23.9% 21/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Thromboembolic Event	4.7% 6/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	8.7% 11/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	4.5% 4/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Lymphedema	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Hypotension	1.6% 2/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.9% 5/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	3.4% 3/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Hypertension	21.3% 27/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	38.6% 49/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	34.1% 30/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Hot Flashes	27.6% 35/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	11.0% 14/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	14.8% 13/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Flushing	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.4% 3/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Vascular disorders Superior Vena Cava Syndrome	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Reproductive system and breast disorders Genital Edema	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic and Mediastinal Disorders	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Cardiac Arrest	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Heart Failure	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Eye disorders Flashing lights	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Cardiac disorders Chest pain - Cardiac	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Enterocolitis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Proctitis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Periodontal disease	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Lip pain	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Facial pain	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Infusion related reaction	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Gastrointestinal disorders Esophageal Stenosis	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
General disorders Multi-Organ failure	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Infections and infestations Bladder infection	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Prolapse of intestinal stoma	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	1.1% 1/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.
Psychiatric disorders Delirium	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	0.00% 0/127 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.	2.3% 2/88 • Starting with the first treatment received, and ending 100 days after the last treatment, or at the last following, whichever is sooner. Time frame was approximately 30 months.

Additional Information

Linda Gedeon for Austin Miller, PhD

NRG Oncology

Phone: 716-845-1169

Email: linda.gedeon@roswellpark.org

Results disclosure agreements

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

Restriction type: LTE60