Trial Outcomes & Findings for Cisplatin vs Paclitaxel for Triple Negative Breast Cancer (NCT NCT01982448)

NCT ID: NCT01982448

Last Updated: 2025-09-26

Results Overview

Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score \>/= 33.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 147 participants
• Primary outcome timeframe: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
• Results posted on: 2025-09-26

Participant Flow

From April 2014 through January 2018

Participant milestones

Measure	Arm A: Cisplatin Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.	Arm B: Paclitaxel Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
Preoperative Chemotherapy STARTED	75	72
Preoperative Chemotherapy Eligible & Treated	72	70
Preoperative Chemotherapy Evaluable for Safety	72	68
Preoperative Chemotherapy COMPLETED	72	67
Preoperative Chemotherapy NOT COMPLETED	3	5
Definitive Breast Surgery STARTED	72	67
Definitive Breast Surgery Evaluable for Response by Homologous Recombination Deficiency (HRD)	56	48
Definitive Breast Surgery COMPLETED	72	67
Definitive Breast Surgery NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Arm A: Cisplatin Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.	Arm B: Paclitaxel Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
Preoperative Chemotherapy Withdrawal by Subject	2	2
Preoperative Chemotherapy Ineligible Prior to Starting Therapy	1	0
Preoperative Chemotherapy Hypersensitivity during cycle 1 so therapy stopped	0	2
Preoperative Chemotherapy Lost to Follow-up	0	1

Baseline Characteristics

The analysis population is comprised of all participants with evaluable tissue for HRD analysis and who completed definitive breast surgery.

Baseline characteristics by cohort

Measure	Arm A: Cisplatin n=75 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.	Arm B: Paclitaxel n=72 Participants Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.	Total n=147 Participants Total of all reporting groups
Age, Continuous	51 years n=75 Participants	53.5 years n=72 Participants	53 years n=147 Participants
Sex: Female, Male Female	75 Participants n=75 Participants	72 Participants n=72 Participants	147 Participants n=147 Participants
Sex: Female, Male Male	0 Participants n=75 Participants	0 Participants n=72 Participants	0 Participants n=147 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=75 Participants	4 Participants n=72 Participants	11 Participants n=147 Participants
Race (NIH/OMB) Asian	0 Participants n=75 Participants	2 Participants n=72 Participants	2 Participants n=147 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=75 Participants	0 Participants n=72 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Black or African American	8 Participants n=75 Participants	11 Participants n=72 Participants	19 Participants n=147 Participants
Race (NIH/OMB) White	60 Participants n=75 Participants	51 Participants n=72 Participants	111 Participants n=147 Participants
Race (NIH/OMB) More than one race	0 Participants n=75 Participants	0 Participants n=72 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=75 Participants	4 Participants n=72 Participants	4 Participants n=147 Participants
Region of Enrollment United States	75 Participants n=75 Participants	72 Participants n=72 Participants	147 Participants n=147 Participants
BRCA1/2 Status Germline/somatic intact	69 Participants n=75 Participants	71 Participants n=72 Participants	140 Participants n=147 Participants
BRCA1/2 Status Germline and/or somatic mutation	6 Participants n=75 Participants	1 Participants n=72 Participants	7 Participants n=147 Participants
Clinical lymph node status Positive	29 Participants n=75 Participants	26 Participants n=72 Participants	55 Participants n=147 Participants
Clinical lymph node status Negative	46 Participants n=75 Participants	46 Participants n=72 Participants	92 Participants n=147 Participants
Homologous Recombination Deficiency (HRD) Status HRD High (+) Status	39 Participants n=56 Participants • The analysis population is comprised of all participants with evaluable tissue for HRD analysis and who completed definitive breast surgery.	35 Participants n=48 Participants • The analysis population is comprised of all participants with evaluable tissue for HRD analysis and who completed definitive breast surgery.	74 Participants n=104 Participants • The analysis population is comprised of all participants with evaluable tissue for HRD analysis and who completed definitive breast surgery.
Homologous Recombination Deficiency (HRD) Status HRD Low (-) Status	17 Participants n=56 Participants • The analysis population is comprised of all participants with evaluable tissue for HRD analysis and who completed definitive breast surgery.	13 Participants n=48 Participants • The analysis population is comprised of all participants with evaluable tissue for HRD analysis and who completed definitive breast surgery.	30 Participants n=104 Participants • The analysis population is comprised of all participants with evaluable tissue for HRD analysis and who completed definitive breast surgery.

PRIMARY outcome

Timeframe: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Population: The analysis population is comprised of all participants with evaluable tissue for HRD analysis and who completed definitive breast surgery.

Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.

Outcome measures

Measure	Arm A: Cisplatin With HRD+ n=39 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm A: Cisplatin With HRD- n=17 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)	Arm B: Paclitaxel With HRD+ n=35 Participants Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm B: Paclitaxel With HRD- n=13 Participants Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)
Number of Participants With Pathologic Response by HR-deficiency (HRD) Status Responder (RCB-0/1)	9 Participants	2 Participants	10 Participants	4 Participants
Number of Participants With Pathologic Response by HR-deficiency (HRD) Status Non-Responder (RCB-2/3 or crossover)	30 Participants	15 Participants	25 Participants	9 Participants

SECONDARY outcome

Timeframe: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Population: The analysis population is comprised of all participants with evaluable tissue for HRD analysis and who completed definitive breast surgery.

Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). pCR is defined as RCB-0. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.

Outcome measures

Measure	Arm A: Cisplatin With HRD+ n=39 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm A: Cisplatin With HRD- n=17 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)	Arm B: Paclitaxel With HRD+ n=35 Participants Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm B: Paclitaxel With HRD- n=13 Participants Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)
Number With Pathologic Complete Response (pCR) by HR-deficiency (HRD) Status pCR	5 Participants	1 Participants	5 Participants	3 Participants
Number With Pathologic Complete Response (pCR) by HR-deficiency (HRD) Status No pCR	34 Participants	16 Participants	30 Participants	10 Participants

SECONDARY outcome

Timeframe: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.

Outcome measures

Measure	Arm A: Cisplatin With HRD+ n=72 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm A: Cisplatin With HRD- n=67 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)	Arm B: Paclitaxel With HRD+ Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm B: Paclitaxel With HRD- Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)
Number of Pathologic Response Responder (RCB-0/1)	19 Participants	15 Participants	—	—
Number of Pathologic Response Non-responder (RCB-2/3 or crossover)	53 Participants	52 Participants	—	—

SECONDARY outcome

Timeframe: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33.

Outcome measures

Measure	Arm A: Cisplatin With HRD+ n=72 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm A: Cisplatin With HRD- n=67 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)	Arm B: Paclitaxel With HRD+ Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm B: Paclitaxel With HRD- Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)
Number With Pathologic Response pCR	11 Participants	8 Participants	—	—
Number With Pathologic Response Non-pCR	61 Participants	59 Participants	—	—

SECONDARY outcome

Timeframe: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.

Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score >/= 33. PPV was calculated as the probability of pathological response among the HRD positive group.

Outcome measures

Measure	Arm A: Cisplatin With HRD+ n=39 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm A: Cisplatin With HRD- n=35 Participants Cisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)	Arm B: Paclitaxel With HRD+ Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD+ (score \>/=33)	Arm B: Paclitaxel With HRD- Paclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy. HRD- (score \<33)
Positive Predictive Value (PPV) of HRD Score	.231 probability	.286 probability	—	—

Adverse Events

Paclitaxel

Serious events: 11 serious events

Other events: 72 other events

Deaths: 0 deaths

Cisplatin

Serious events: 19 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paclitaxel n=72 participants at risk Paclitaxel will be given as an IV infusion at a dose of 80mg/m2 weekly x 12 weeks (4 cycles).	Cisplatin n=67 participants at risk Cisplatin will be given by IV at 75 mg/m2 every 3 weeks, 4 cycles.
Blood and lymphatic system disorders Leukocytosis	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Nausea	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Vomiting	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Lymphocyte count decreased	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Neutrophil count decreased	6.9% 5/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	11.9% 8/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations White blood cell decreased	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Dehydration	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypophosphatemia	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Nasal congestion	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Thromboembolic event	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Other adverse events

Measure	Paclitaxel n=72 participants at risk Paclitaxel will be given as an IV infusion at a dose of 80mg/m2 weekly x 12 weeks (4 cycles).	Cisplatin n=67 participants at risk Cisplatin will be given by IV at 75 mg/m2 every 3 weeks, 4 cycles.
Ear and labyrinth disorders Ear pain	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Hearing impaired	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Tinnitus	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	7.5% 5/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Vertigo	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Anemia	51.4% 37/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	49.3% 33/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	7.5% 5/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Atrial fibrillation	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Chest pain - cardiac	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Mitral valve disease	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Palpitations	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Sick sinus syndrome	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Sinus bradycardia	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Sinus tachycardia	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Ventricular arrhythmia	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Cardiac disorders - Other	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Chills	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Edema limbs	5.6% 4/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	70.8% 51/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	82.1% 55/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Fever	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Flu like symptoms	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Infusion related reaction	11.1% 8/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Irritability	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Localized edema	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Non-cardiac chest pain	12.5% 9/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Pain	13.9% 10/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	7.5% 5/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders General disorders and administration site conditions - Other	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Alopecia	58.3% 42/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Dry skin	9.7% 7/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Nail discoloration	8.3% 6/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Pruritus	9.7% 7/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Rash acneiform	19.4% 14/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 8/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Scalp pain	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	15.3% 11/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Endocrine disorders Hypothyroidism	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	9.0% 6/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Endocrine disorders Endocrine disorders - Other	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Abdominal pain	8.3% 6/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	6.0% 4/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Bloating	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Colitis	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Constipation	26.4% 19/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	46.3% 31/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Diarrhea	31.9% 23/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	23.9% 16/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dry mouth	6.9% 5/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dyspepsia	13.9% 10/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	9.0% 6/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dysphagia	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Flatulence	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Gastroesophageal reflux disease	13.9% 10/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	17.9% 12/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Gastrointestinal pain	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Hemorrhoids	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Mucositis oral	8.3% 6/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	6.0% 4/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Nausea	43.1% 31/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	85.1% 57/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Oral dysesthesia	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Oral pain	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Stomach pain	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Vomiting	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	19.4% 13/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Gastrointestinal disorders - Other	5.6% 4/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	6.0% 4/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Hepatobiliary disorders Hepatobiliary disorders - Other	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Immune system disorders Allergic reaction	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Bladder infection	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Breast infection	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Bronchial infection	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Gum infection	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Laryngitis	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Otitis media	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Papulopustular rash	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Sinusitis	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Upper respiratory infection	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Urinary tract infection	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	6.0% 4/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Vaginal infection	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infections and infestations - Other	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Bruising	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Wound complication	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Wrist fracture	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Alanine aminotransferase increased	22.2% 16/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	9.0% 6/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Alkaline phosphatase increased	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	14.9% 10/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Aspartate aminotransferase increased	19.4% 14/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	11.9% 8/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Blood bilirubin increased	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Cardiac troponin T increased	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations CD4 lymphocytes decreased	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Cholesterol high	12.5% 9/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Creatinine increased	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	14.9% 10/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Hemoglobin increased	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Lymphocyte count decreased	8.3% 6/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Lymphocyte count increased	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Neutrophil count decreased	33.3% 24/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	58.2% 39/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Platelet count decreased	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	23.9% 16/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Weight gain	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Weight loss	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations White blood cell decreased	34.7% 25/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	43.3% 29/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Investigations - Other	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Anorexia	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	6.0% 4/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Dehydration	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypercalcemia	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyperglycemia	16.7% 12/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	17.9% 12/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypermagnesemia	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypertriglyceridemia	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypoalbuminemia	9.7% 7/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	11.9% 8/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypocalcemia	9.7% 7/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	10.4% 7/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypoglycemia	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	7.5% 5/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypokalemia	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	11.9% 8/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypomagnesemia	6.9% 5/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	34.3% 23/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyponatremia	8.3% 6/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	7.5% 5/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypophosphatemia	8.3% 6/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	10.4% 7/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Obesity	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other,	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	7.5% 5/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Arthralgia	15.3% 11/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	7.5% 5/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Arthritis	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	7.5% 5/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Back pain	8.3% 6/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	19.4% 13/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Bone pain	11.1% 8/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Chest wall pain	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Growth suppression	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Joint range of motion decreased cervical spine	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Myalgia	18.1% 13/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Neck pain	5.6% 4/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Neck soft tissue necrosis	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Osteoporosis	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Pain in extremity	9.7% 7/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	6.9% 5/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	9.0% 6/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Akathisia	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Dizziness	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	13.4% 9/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Dysgeusia	20.8% 15/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	16.4% 11/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Encephalopathy	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Headache	34.7% 25/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	26.9% 18/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Hypersomnia	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Memory impairment	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Paresthesia	9.7% 7/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Peripheral motor neuropathy	15.3% 11/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	6.0% 4/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Peripheral sensory neuropathy	55.6% 40/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	14.9% 10/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Presyncope	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Nervous system disorders - Other	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Eye disorders Blurred vision	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Eye disorders Conjunctivitis	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Eye disorders Dry eye	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Eye disorders Flashing lights	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Eye disorders Glaucoma	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Eye disorders Watering eyes	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Eye disorders Eye disorders - Other	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Agitation	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Anxiety	33.3% 24/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	25.4% 17/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Depression	19.4% 14/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	10.4% 7/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Hallucinations	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Insomnia	33.3% 24/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	22.4% 15/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Libido decreased	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Psychiatric disorders - Other	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.6% 4/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	6.0% 4/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 6/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 12/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.9% 5/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	6.0% 4/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Postnasal drip	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Sinus disorder	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Sore throat	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Tracheal fistula	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Wheezing	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	4.2% 3/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	4.5% 3/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Acute kidney injury	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	6.0% 4/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Renal and urinary disorders Bladder spasm	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Renal and urinary disorders Urinary frequency	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Renal and urinary disorders Urinary incontinence	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Renal and urinary disorders Surgical and medical procedures - Other	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Reproductive system and breast disorders Breast pain	16.7% 12/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	14.9% 10/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Reproductive system and breast disorders Irregular menstruation	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Reproductive system and breast disorders Vaginal inflammation	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Reproductive system and breast disorders Vaginal pain	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Reproductive system and breast disorders Menopause	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Reproductive system and breast disorders Reproductive system and breast disorders - Other	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Flushing	2.8% 2/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Hot flashes	18.1% 13/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	11.9% 8/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Hypertension	30.6% 22/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	28.4% 19/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Hypotension	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Lymphedema	1.4% 1/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	0.00% 0/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Superficial thrombophlebitis	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	3.0% 2/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Vascular disorders - Other	0.00% 0/72 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.	1.5% 1/67 • AE data collected every cycle from the time of the first dose of study treatment, through the study 12 weeks of treatment until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 4 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Additional Information

Clinical Trials Office

Dana-Farber Cancer Institute

Phone: 617-632-5313

Email: ctopm@dfci.harvard.edu

Results disclosure agreements

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