Trial Outcomes & Findings for Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma (NCT NCT02601209)

Last Updated: 2022-08-23

Results Overview

The Maximum Tolerated Dose (MTD) of sapanisertib (MLN0128) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event is reported.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

151 participants

Primary outcome timeframe

28 days

Results posted on

2022-08-23

Participant Flow

Phase II Analysis Group 1: 32 Patients pre-registered; 7 did not pass screening, leaving 25 to proceed to randomization. Phase II Analysis Group 2: 166 Patients pre-registered; 52 did not pass screening, leaving 114 to proceed to randomization.

Participant milestones

Participant milestones
Measure	Phase I - Dose Level 0 Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 1 Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 2 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase II - Analysis Group 1 Pazopanib Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.	Phase II - Analysis Group 1 MLN0128 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 2 Pazopanib Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 1 Pazopanib Crossover Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.	Phase II - Analysis Group 2 Pazopanib Crossover Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.
Initial Treatment (Up to 4 Months) STARTED	4	4	4	6	13	15	56	6	43
Initial Treatment (Up to 4 Months) COMPLETED	3	3	3	6	12	13	55	6	43
Initial Treatment (Up to 4 Months) NOT COMPLETED	1	1	1	0	1	2	1	0	0
Optional Crossover (Up to 2 Months) STARTED	0	0	0	0	0	0	0	6	43
Optional Crossover (Up to 2 Months) COMPLETED	0	0	0	0	0	0	0	4	26
Optional Crossover (Up to 2 Months) NOT COMPLETED	0	0	0	0	0	0	0	2	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I - Dose Level 0 Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 1 Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 2 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase II - Analysis Group 1 Pazopanib Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.	Phase II - Analysis Group 1 MLN0128 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 2 Pazopanib Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 1 Pazopanib Crossover Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.	Phase II - Analysis Group 2 Pazopanib Crossover Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.
Initial Treatment (Up to 4 Months) Did not meet eligibility criteria	1	1	1	0	0	0	0	0	0
Initial Treatment (Up to 4 Months) Withdrew before initiation of regimen	0	0	0	0	1	2	1	0	0

Baseline Characteristics

Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I - Dose Level 0 n=3 Participants Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 1 n=3 Participants Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 2 n=3 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase II - Analysis Group 1 MLN0128 n=13 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 1 Pazopanib n=12 Participants Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=56 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 2 Pazopanib n=58 Participants Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Total n=148 Participants Total of all reporting groups
Age, Continuous	47.3 years STANDARD_DEVIATION 4.7 • n=5 Participants	56.3 years STANDARD_DEVIATION 12.3 • n=7 Participants	48.7 years STANDARD_DEVIATION 16.0 • n=5 Participants	53.2 years STANDARD_DEVIATION 11.2 • n=4 Participants	53.0 years STANDARD_DEVIATION 16.0 • n=21 Participants	59.7 years STANDARD_DEVIATION 13.4 • n=8 Participants	55.7 years STANDARD_DEVIATION 13.6 • n=8 Participants	56.4 years STANDARD_DEVIATION 13.5 • n=24 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	40 Participants n=8 Participants	37 Participants n=8 Participants	96 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants	4 Participants n=21 Participants	16 Participants n=8 Participants	21 Participants n=8 Participants	52 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	10 Participants n=24 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants	10 Participants n=21 Participants	44 Participants n=8 Participants	48 Participants n=8 Participants	120 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants	6 Participants n=8 Participants	13 Participants n=24 Participants
ECOG Performance Status 0	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	35 Participants n=8 Participants	28 Participants n=8 Participants	84 Participants n=24 Participants
ECOG Performance Status 1	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	21 Participants n=8 Participants	30 Participants n=8 Participants	64 Participants n=24 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Phase I

Outcome measures

Outcome measures
Measure	Phase II - Analysis Group 2 Pazopanib n=3 Participants Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=3 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase I - Dose Level 2 n=3 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: Phase II Analysis Group 2 - Initial Treatment Period

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and an upper confidence boundary from a 1-sided, 85% confidence interval are estimated using the Kaplan-Meier methods.

Outcome measures

Outcome measures
Measure	Phase II - Analysis Group 2 Pazopanib n=58 Participants Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=56 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase I - Dose Level 2 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period)	2.1 months Interval 1.9 to 3.7	2.0 months Interval 1.9 to 3.0	—

SECONDARY outcome

Timeframe: Up to 4 months

Population: Phase II Analysis Group 2 - Initial Treatment Period; This analysis excludes cancel patients (who never received treatment i.e. Withdrew before initiation of regimen )

The number of patients who experienced grade 3+ adverse events for Phase II Analysis Group 2 for the initial treatment period is reported below.

Outcome measures

Outcome measures
Measure	Phase II - Analysis Group 2 Pazopanib n=56 Participants Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=55 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase I - Dose Level 2 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period)	38 Participants	28 Participants	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Phase II Analysis Group 2 - Initial Treatment Period; Patients with tumor response data available are included in this analysis.

The frequencies (and percentages) of tumor response categories (CR, PR, SD, PD) will be summarized for Phase II Analysis Group 2. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion, b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.

Outcome measures

Outcome measures
Measure	Phase II - Analysis Group 2 Pazopanib n=51 Participants Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=44 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase I - Dose Level 2 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) Complete Response	0 Participants	0 Participants	—
Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) Partial Response	2 Participants	2 Participants	—
Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) Stable Disease	23 Participants	14 Participants	—
Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period) Progressive Disease	26 Participants	28 Participants	—

SECONDARY outcome

Timeframe: Time between each patient's best tumor response and progression(or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years

Population: Phase II Analysis Group 2 - Initial Treatment Period; Only patients that had a complete response or partial response are included in this analysis.

Duration of response is defined as the time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up). Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD.

Outcome measures

Outcome measures
Measure	Phase II - Analysis Group 2 Pazopanib n=2 Participants Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=2 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase I - Dose Level 2 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
Duration of Response (Phase II Analysis Group 2 - Initial Treatment Period)	1.8 months Interval 0.0 to 3.6	0.9 months Interval 0.0 to 1.84	—

SECONDARY outcome

Timeframe: Up to 6 months

Population: Phase II Analysis Group 2 - Initial Treatment Period

Will be defined as the number of patients having either complete response (CR), partial response (PR), or stable disease for at least 6 months after starting treatment. The frequencies and rates of tumor response categories (CR, PR, SD, PD, and too early/not evaluated) will be summarized by dose cohort and treatment arm. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.

Outcome measures

Outcome measures
Measure	Phase II - Analysis Group 2 Pazopanib n=58 Participants Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=56 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase I - Dose Level 2 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
Number of Patients Having CR, PR, or SD at 6 Months (Phase II Analysis Group 2 - Initial Treatment Period)	5 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Time between randomization and disease progression, assessed up to 2 years

Population: Phase II Analysis Group 2 - Initial Treatment Period

Time to progression is defined as the time between randomization and disease progression. Kaplan-Meier methodology will be used to estimate the distribution of TTP. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. Symptomatic deterioration.

Outcome measures

Outcome measures
Measure	Phase II - Analysis Group 2 Pazopanib n=58 Participants Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=56 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase I - Dose Level 2 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
Time to Progression (TTP) (Phase II Analysis Group 2 - Initial Treatment Period)	2.1 months Interval 1.9 to 3.7	2.0 months Interval 1.9 to 3.0	—

SECONDARY outcome

Timeframe: Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years

Population: Phase II Analysis Group 2 - Initial Treatment Period

Overall survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period). Kaplan-Meier methodology will be used to estimate the distribution of OS.

Outcome measures

Outcome measures
Measure	Phase II - Analysis Group 2 Pazopanib n=58 Participants Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=56 Participants Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase I - Dose Level 2 Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
Overall Survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period)	13.7 months Interval 10.3 to The 95% confidence interval upper limit was not estimable (i.e. insufficient number of participants with events).	12.2 months Interval 7.5 to 16.3	—

Deaths: 27 deaths

Phase II - Analysis Group 2 Pazopanib

Serious events: 24 serious events

Other events: 55 other events

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Phase I - Dose Level 0 n=3 participants at risk Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 1 n=3 participants at risk Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 2 n=3 participants at risk Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase II - Analysis Group 1 MLN0128 n=12 participants at risk Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 1 Pazopanib n=12 participants at risk Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=55 participants at risk Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 2 Pazopanib n=56 participants at risk Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Cardiac disorders Cardiac arrest	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Cardiac disorders Heart failure	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Eye disorders Retinal tear	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.4% 3/56 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Fecal incontinence	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Jejunal perforation	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Nausea	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Death NOS	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Fatigue	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Fever	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Gait disturbance	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.4% 3/56 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Abdominal infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Enterocolitis infectious	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Lung infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Mucosal infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Sepsis	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Wound infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Blood bilirubin increased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Creatinine increased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Lymphocyte count decreased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Neutrophil count decreased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Weight loss	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.1% 4/56 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Dizziness	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Encephalopathy	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Headache	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Seizure	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Reproductive system and breast disorders Perineal pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Hematoma	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Hypertension	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Hypotension	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Thromboembolic event	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.

Other adverse events

Other adverse events
Measure	Phase I - Dose Level 0 n=3 participants at risk Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 1 n=3 participants at risk Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase I - Dose Level 2 n=3 participants at risk Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.	Phase II - Analysis Group 1 MLN0128 n=12 participants at risk Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 1 Pazopanib n=12 participants at risk Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.	Phase II - Analysis Group 2 MLN0128 n=55 participants at risk Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.	Phase II - Analysis Group 2 Pazopanib n=56 participants at risk Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
Eye disorders Retinal tear	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	50.0% 6/12 • Number of events 15 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	20.0% 11/55 • Number of events 21 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	28.6% 16/56 • Number of events 27 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.1% 4/56 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Cardiac disorders Palpitations	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Cardiac disorders Pericardial effusion	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.1% 4/56 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 15 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Endocrine disorders Hypoparathyroidism	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.1% 4/56 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Eye disorders Blurred vision	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Eye disorders Dry eye	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Eye disorders Eye disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Eye disorders Eye pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Eye disorders Floaters	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Eye disorders Scleral disorder	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 10 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	21.4% 12/56 • Number of events 19 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Ascites	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Bloating	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Colonic hemorrhage	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	14.5% 8/55 • Number of events 12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	10.7% 6/56 • Number of events 12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	66.7% 2/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	58.3% 7/12 • Number of events 15 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	58.3% 7/12 • Number of events 30 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	30.9% 17/55 • Number of events 40 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	53.6% 30/56 • Number of events 90 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Esophagitis	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Fecal incontinence	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.4% 3/56 • Number of events 10 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Gastritis	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 11 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 4/12 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.5% 14/55 • Number of events 24 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	12.5% 7/56 • Number of events 17 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Nausea	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	100.0% 3/3 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	66.7% 2/3 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	58.3% 7/12 • Number of events 16 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	41.7% 5/12 • Number of events 16 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	60.0% 33/55 • Number of events 67 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	41.1% 23/56 • Number of events 54 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Oral dysesthesia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Periodontal disease	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Rectal pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Stomach pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 14 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	66.7% 2/3 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	50.0% 6/12 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	34.5% 19/55 • Number of events 29 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	26.8% 15/56 • Number of events 30 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Chills	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Edema limbs	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	14.3% 8/56 • Number of events 15 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Fatigue	100.0% 3/3 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	100.0% 3/3 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	100.0% 3/3 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	83.3% 10/12 • Number of events 24 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	91.7% 11/12 • Number of events 29 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	78.2% 43/55 • Number of events 99 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	71.4% 40/56 • Number of events 120 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Fever	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Flu like symptoms	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.4% 3/56 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Localized edema	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Malaise	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Non-cardiac chest pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
General disorders Pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.3% 4/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.1% 4/56 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Immune system disorders Allergic reaction	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Abdominal infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Anorectal infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Enterocolitis infectious	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Papulopustular rash	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Sepsis	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Sinusitis	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Skin infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Upper respiratory infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Infections and infestations Wound infection	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 4/12 • Number of events 17 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	17.9% 10/56 • Number of events 18 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Alkaline phosphatase increased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	9.1% 5/55 • Number of events 10 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	14.3% 8/56 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 4/12 • Number of events 15 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 13 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	21.4% 12/56 • Number of events 22 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Blood bilirubin increased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	10.7% 6/56 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Cholesterol high	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Creatinine increased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	9.1% 5/55 • Number of events 12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.4% 3/56 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Ejection fraction decreased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Investigations - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.1% 4/56 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Lipase increased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Lymphocyte count decreased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	18.2% 10/55 • Number of events 32 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.1% 9/56 • Number of events 22 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Neutrophil count decreased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 15 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.1% 9/56 • Number of events 15 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Platelet count decreased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	66.7% 2/3 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	50.0% 6/12 • Number of events 14 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	23.6% 13/55 • Number of events 20 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 14/56 • Number of events 36 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations Weight loss	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	66.7% 2/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.4% 9/55 • Number of events 21 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	19.6% 11/56 • Number of events 30 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Investigations White blood cell decreased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	100.0% 3/3 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.3% 4/55 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	12.5% 7/56 • Number of events 14 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	100.0% 3/3 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	41.7% 5/12 • Number of events 11 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	50.0% 6/12 • Number of events 24 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	58.2% 32/55 • Number of events 54 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	39.3% 22/56 • Number of events 82 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	10.9% 6/55 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.4% 3/56 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hyperglycemia	66.7% 2/3 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	66.7% 2/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	75.0% 9/12 • Number of events 20 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	49.1% 27/55 • Number of events 58 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 14/56 • Number of events 21 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.3% 4/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.3% 4/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	17.9% 10/56 • Number of events 16 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	10.7% 6/56 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.3% 4/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.9% 5/56 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	14.3% 8/56 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.1% 4/56 • Number of events 13 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 4/12 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 7 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	10.7% 6/56 • Number of events 34 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Dizziness	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.3% 4/55 • Number of events 10 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.1% 4/56 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Dysgeusia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 10 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 14 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.1% 9/56 • Number of events 29 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	66.7% 2/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	14.5% 8/55 • Number of events 26 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	21.4% 12/56 • Number of events 17 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Memory impairment	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Paresthesia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Phantom pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Nervous system disorders Somnolence	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Psychiatric disorders Agitation	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Psychiatric disorders Delirium	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Psychiatric disorders Depression	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Psychiatric disorders Insomnia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Psychiatric disorders Restlessness	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Hematuria	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Renal calculi	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Urinary frequency	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Urinary tract pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Renal and urinary disorders Urine discoloration	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.3% 4/55 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	12.5% 7/56 • Number of events 12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 6 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	12.5% 7/56 • Number of events 21 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	16.7% 2/12 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.4% 3/56 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 10 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 10 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	5.5% 3/55 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	18.2% 10/55 • Number of events 18 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	12.5% 7/56 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	25.0% 3/12 • Number of events 12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	7.1% 4/56 • Number of events 5 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/56 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 4 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Flushing	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 1/3 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Hot flashes	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/55 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Hypertension	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	66.7% 2/3 • Number of events 9 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	33.3% 4/12 • Number of events 8 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	58.3% 7/12 • Number of events 26 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	36.4% 20/55 • Number of events 47 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	66.1% 37/56 • Number of events 129 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Hypotension	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	8.3% 1/12 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Lymphedema	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	3.6% 2/55 • Number of events 2 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/56 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.
Vascular disorders Thromboembolic event	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/3 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	0.00% 0/12 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/55 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.	1.8% 1/56 • Number of events 1 • Up to 2 years Adverse events from all registered Phase I and randomized Phase II patients who initiated treatment (Initial treatment period) and had adverse events assessed are summarized below.

Additional Information

William D. Tap, MD

Memorial Sloan-Kettering Cancer Center

Phone: 646-888-4156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60