Trial Outcomes & Findings for Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer (NCT NCT02101385)

NCT ID: NCT02101385

Last Updated: 2023-09-28

Results Overview

Two-year disease-free survival (DFS) in participants with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy. The survival probabilities for arm A and arm B were estimated as 2 year disease free survival. DFS is defined as the duration of time from randomization to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 193 participants
• Primary outcome timeframe: From C1D1 until death or up to a maximum of 24 months.
• Results posted on: 2023-09-28

Participant Flow

Participant milestones

Measure	Arm A (Genomically Directed Monotherapy) Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Study Treatment STARTED	71	122
Study Treatment COMPLETED	45	110
Study Treatment NOT COMPLETED	26	12
Follow up STARTED	70	122
Follow up COMPLETED	3	9
Follow up NOT COMPLETED	67	113

Reasons for withdrawal

Measure	Arm A (Genomically Directed Monotherapy) Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Study Treatment Disease Progression	9	3
Study Treatment Alternative therapy	0	1
Study Treatment No treatment, per protocol criteria	0	4
Study Treatment Patient Non compliance	0	2
Study Treatment Withdrawal by Subject	5	2
Study Treatment screen failure	1	0
Study Treatment AE/Side Effects/Complications	8	0
Study Treatment Lost to Follow-up	1	0
Study Treatment Disease Progression before treatment	1	0
Study Treatment Death	1	0
Follow up Lost to Follow-up	4	9
Follow up Refused to follow up	5	4
Follow up Death	21	39
Follow up study completed	33	52
Follow up screen failure	2	0
Follow up Pt. moved tx to Cancer Treatment Centers of America (Georgia). last contact was verbal on 3/10/16	0	1
Follow up Disease progression - elected to participate in another clinical trial with no more follow up	0	1
Follow up Withdrawal by Subject	2	2
Follow up PI requested closure of site	0	5

Baseline Characteristics

Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer

Baseline characteristics by cohort

Measure	Arm A (Genomically Directed Monotherapy) n=71 Participants Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) n=122 Participants Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.	Total n=193 Participants Total of all reporting groups
Age, Customized <= 45	29 Participants n=5 Participants	40 Participants n=7 Participants	69 Participants n=5 Participants
Age, Customized 46-60	32 Participants n=5 Participants	54 Participants n=7 Participants	86 Participants n=5 Participants
Age, Customized 61-75	10 Participants n=5 Participants	27 Participants n=7 Participants	37 Participants n=5 Participants
Age, Customized >= 76	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	122 Participants n=7 Participants	193 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	106 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	34 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	85 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
ECOG Performance Status 0	60 Participants n=5 Participants	100 Participants n=7 Participants	160 Participants n=5 Participants
ECOG Performance Status 1	11 Participants n=5 Participants	21 Participants n=7 Participants	32 Participants n=5 Participants
ECOG Performance Status 2	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Pathologic T stage at surgery T1	22 Participants n=5 Participants	51 Participants n=7 Participants	73 Participants n=5 Participants
Pathologic T stage at surgery T2	27 Participants n=5 Participants	51 Participants n=7 Participants	78 Participants n=5 Participants
Pathologic T stage at surgery T3	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Pathologic T stage at surgery T4	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Pathologic T stage at surgery Unknown	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Pathologic N stage at surgery N0	40 Participants n=5 Participants	65 Participants n=7 Participants	105 Participants n=5 Participants
Pathologic N stage at surgery N1	15 Participants n=5 Participants	34 Participants n=7 Participants	49 Participants n=5 Participants
Pathologic N stage at surgery N2	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Pathologic N stage at surgery N3	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Pathologic N stage at surgery Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
M stage M0	44 Participants n=5 Participants	86 Participants n=7 Participants	130 Participants n=5 Participants
M stage Unknown	27 Participants n=5 Participants	36 Participants n=7 Participants	63 Participants n=5 Participants
Histologic grade 1	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Histologic grade 2	6 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants
Histologic grade 3	64 Participants n=5 Participants	102 Participants n=7 Participants	166 Participants n=5 Participants
Histologic grade Unknown	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Lymph node involvement Yes	30 Participants n=5 Participants	58 Participants n=7 Participants	88 Participants n=5 Participants
Lymph node involvement No	41 Participants n=5 Participants	63 Participants n=7 Participants	104 Participants n=5 Participants
Lymph node involvement Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
RCB classsification II	33 Participants n=5 Participants	54 Participants n=7 Participants	87 Participants n=5 Participants
RCB classsification III	14 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants
RCB classsification Unknown	24 Participants n=5 Participants	46 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: From C1D1 until death or up to a maximum of 24 months.

Two-year disease-free survival (DFS) in participants with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy. The survival probabilities for arm A and arm B were estimated as 2 year disease free survival.

DFS is defined as the duration of time from randomization to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause.

Outcome measures

Measure	Arm A (Genomically Directed Monotherapy) n=71 Participants Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) n=122 Participants Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Percentage of Participants With Two-Year Disease-Free Survival (DFS)	56.6 percentage of participants	62.4 percentage of participants

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 58 months

Overall DFS in participants of arm A and B were compared with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy.

DFS is defined as the duration of time from randomization to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause.

Outcome measures

Measure	Arm A (Genomically Directed Monotherapy) n=71 Participants Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) n=122 Participants Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Comparison Between Overall Disease-Free Survival	NA months Interval 16.6 to Arm A did not drop to 50 % survival at the end of the available data, therefore neither the median nor upper limit could be calculated.	48.7 months Interval 20.8 to Upper limit could not be reached since there weren't enough events at later times to get reliable upper CI for arm B.

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 12 months

One year DFS in participants of arm A and B were compared with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy. The survival probabilities for arm A and arm B were estimated as 1 year disease free survival.

Disease Free Survival is defined as the duration of time from randomization to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause.

Outcome measures

Measure	Arm A (Genomically Directed Monotherapy) n=71 Participants Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) n=122 Participants Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Comparison Between One Year Disease Free Survival	63.5 percentage of participants	72.7 percentage of participants

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 60 months

5-year overall survival (OS) in participants is determind with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy. Here 5 - year survival probability to compare arms A and B has been reported.

Overall Survival is defined as the time from start of treatment to death from any cause. Subjects who are alive are censored at their last visit dates.

Outcome measures

Measure	Arm A (Genomically Directed Monotherapy) n=71 Participants Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) n=122 Participants Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Five-Year Overall Survival (OS) Rate	0.52 probability	0.62 probability

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 60 months

The safety and tolerability of the experimental arm A(genomically directed monotherapy) and control arm B(standard therapy) has been assessed using CTCAE v4.0. Number of subjects who had any adverse events or events greater than grade 3 were reported in this outcome measure.

Outcome measures

Measure	Arm A (Genomically Directed Monotherapy) n=71 Participants Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) n=122 Participants Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Number of Patients With Adverse Events as a Measure of Safety and Tolerability Number of patients had at least one adverse event of any grade	65 Participants	34 Participants
Number of Patients With Adverse Events as a Measure of Safety and Tolerability Number of patients had at least one grade 3 or greater adverse event	23 Participants	10 Participants
Number of Patients With Adverse Events as a Measure of Safety and Tolerability Number of patients had at least one grade 3 or greater treatment related adverse event	23 Participants	10 Participants
Number of Patients With Adverse Events as a Measure of Safety and Tolerability Number of patients having serious adverse event	2 Participants	2 Participants

Adverse Events

Arm A (Genomically Directed Monotherapy)

Serious events: 2 serious events

Other events: 65 other events

Deaths: 22 deaths

Control Arm B (Observation/Standard Therapy)

Serious events: 2 serious events

Other events: 33 other events

Deaths: 39 deaths

Serious adverse events

Measure	Arm A (Genomically Directed Monotherapy) n=71 participants at risk Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) n=122 participants at risk Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Nervous system disorders BRACHIAL PLEXOPATHY	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations LUNG INFECTION	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations BREAST INFECTION	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.

Other adverse events

Measure	Arm A (Genomically Directed Monotherapy) n=71 participants at risk Genomically Directed Monotherapy: Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:	Control Arm B (Observation/Standard Therapy) n=122 participants at risk Observation/Standard Therapy: Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
Gastrointestinal disorders ABDOMINAL PAIN	4.2% 3/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	3.3% 4/122 • Number of events 4 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Psychiatric disorders AGITATION	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations ALANINE AMINOTRANSFERASE INCREASED	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations ALKALINE PHOSPHATASE INCREASED	8.5% 6/71 • Number of events 7 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Immune system disorders ALLERGIC REACTION	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders ALOPECIA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Blood and lymphatic system disorders ANEMIA	8.5% 6/71 • Number of events 10 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Metabolism and nutrition disorders ANOREXIA	12.7% 9/71 • Number of events 12 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Psychiatric disorders ANXIETY	4.2% 3/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders ARTHRALGIA	11.3% 8/71 • Number of events 10 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	5.6% 4/71 • Number of events 4 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders BACK PAIN	18.3% 13/71 • Number of events 15 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations BLOOD BILIRUBIN INCREASED	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Eye disorders BLURRED VISION	4.2% 3/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders BONE PAIN	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations BREAST INFECTION	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Reproductive system and breast disorders BREAST PAIN	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	1.6% 2/122 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders CHEST WALL PAIN	4.2% 3/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Hepatobiliary disorders CHOLECYSTITIS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders CONSTIPATION	21.1% 15/71 • Number of events 19 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders COUGH	12.7% 9/71 • Number of events 11 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations CREATININE INCREASED	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Psychiatric disorders DEPRESSION	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Injury, poisoning and procedural complications DERMATITIS RADIATION	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders DIARRHEA	28.2% 20/71 • Number of events 32 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	6.6% 8/122 • Number of events 9 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders DIZZINESS	4.2% 3/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders DRY SKIN	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders DYSESTHESIA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders DYSGEUSIA	5.6% 4/71 • Number of events 5 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders DYSPEPSIA	7.0% 5/71 • Number of events 5 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders DYSPHAGIA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders DYSPNEA	14.1% 10/71 • Number of events 11 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders EDEMA FACE	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders EDEMA LIMBS	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders FACIAL PAIN	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Injury, poisoning and procedural complications FALL	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders FATIGUE	50.7% 36/71 • Number of events 43 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	6.6% 8/122 • Number of events 8 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders FEVER	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Eye disorders FLASHING LIGHTS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders FLU LIKE SYMPTOMS	2.8% 2/71 • Number of events 7 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Vascular disorders FLUSHING	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	1.4% 1/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders HEADACHE	16.9% 12/71 • Number of events 15 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders HEMORRHOIDS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders HOARSENESS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Vascular disorders HOT FLASHES	5.6% 4/71 • Number of events 4 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Metabolism and nutrition disorders HYPERCALCEMIA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Metabolism and nutrition disorders HYPERGLYCEMIA	5.6% 4/71 • Number of events 6 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Vascular disorders HYPERTENSION	12.7% 9/71 • Number of events 11 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	5.7% 7/122 • Number of events 9 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Endocrine disorders HYPERTHYROIDISM	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Metabolism and nutrition disorders HYPOALBUMINEMIA	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Metabolism and nutrition disorders HYPOKALEMIA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Metabolism and nutrition disorders HYPONATREMIA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Endocrine disorders HYPOTHYROIDISM	5.6% 4/71 • Number of events 5 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations INFECTIONS AND INFESTATIONS	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Psychiatric disorders INSOMNIA	5.6% 4/71 • Number of events 4 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders IRRITABILITY	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Blood and lymphatic system disorders LEUKOCYTOSIS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders LOCALIZED EDEMA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Vascular disorders LYMPHEDEMA	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations LYMPHOCYTE COUNT DECREASED	4.2% 3/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders MEMORY IMPAIRMENT	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations MUCOSAL INFECTION	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders MUCOSITIS ORAL	7.0% 5/71 • Number of events 7 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS TRUNK	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER	4.2% 3/71 • Number of events 4 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders MYALGIA	7.0% 5/71 • Number of events 5 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations NAIL INFECTION	1.4% 1/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders NAIL LOSS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	4.2% 3/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders NAUSEA	32.4% 23/71 • Number of events 34 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	4.9% 6/122 • Number of events 6 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders NECK PAIN	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations NEUTROPHIL COUNT DECREASED	12.7% 9/71 • Number of events 12 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders ORAL DYSESTHESIA	1.4% 1/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders ORAL PAIN	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
General disorders PAIN	5.6% 4/71 • Number of events 5 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.6% 4/71 • Number of events 6 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME	4.2% 3/71 • Number of events 5 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	4.9% 6/122 • Number of events 6 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations PAPULOPUSTULAR RASH	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders PARESTHESIA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Reproductive system and breast disorders PELVIC PAIN	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders PERIORBITAL EDEMA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	12.7% 9/71 • Number of events 10 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	1.6% 2/122 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Psychiatric disorders PERSONALITY CHANGE	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations PLATELET COUNT DECREASED	8.5% 6/71 • Number of events 7 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders PRESYNCOPE	1.4% 1/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders PRURITUS	5.6% 4/71 • Number of events 4 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Psychiatric disorders PSYCHIATRIC DISORDERS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders RASH ACNEIFORM	8.5% 6/71 • Number of events 6 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Nervous system disorders SINUS PAIN	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations SINUSITIS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS	2.8% 2/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations SKIN INFECTION	2.8% 2/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders SKIN ULCERATION	2.8% 2/71 • Number of events 4 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Respiratory, thoracic and mediastinal disorders SORE THROAT	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Musculoskeletal and connective tissue disorders SUPERFICIAL SOFT TISSUE FIBROSIS	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders TELANGIECTASIA	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations UPPER RESPIRATORY INFECTION	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	1.6% 2/122 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations URINARY TRACT INFECTION	4.2% 3/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Infections and infestations VAGINAL INFECTION	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Reproductive system and breast disorders VAGINAL INFLAMMATION	1.4% 1/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders VOMITING	9.9% 7/71 • Number of events 8 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations WEIGHT GAIN	2.8% 2/71 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	1.6% 2/122 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations WEIGHT LOSS	2.8% 2/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Investigations WHITE BLOOD CELL DECREASED	4.2% 3/71 • Number of events 3 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Injury, poisoning and procedural complications WOUND DEHISCENCE	1.4% 1/71 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.00% 0/122 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders BLOATING	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Cardiac disorders CARDIAC DISORDERS	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 2 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Endocrine disorders ENDOCRINE DISORDERS	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders ERYTHEMA MULTIFORME	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders FECAL INCONTINENCE	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Metabolism and nutrition disorders GLUCOSE INTOLERANCE	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Vascular disorders HYPOTENSION	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Cardiac disorders PALPITATIONS	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Injury, poisoning and procedural complications SEROMA	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	0.00% 0/71 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.	0.82% 1/122 • Number of events 1 • From C1D1 up to at least 30 days after final protocol treatment or up to a maximum of 60 months. Adverse events will be recorded from the time of consent and for at least 30 days after final protocol treatment. SAEs must be reported during the course of the study within 24 hours of discovery of the event.

Additional Information

Annesha Majumdar

Hoosier Cancer Research Network

Phone: 3179212050

Email: amajumdar@hoosiercancer.org

Results disclosure agreements

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