Trial Outcomes & Findings for Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer (NCT NCT03377023)

Last Updated: 2026-01-22

Results Overview

Dose escalation to determine the MTD and Recommended Phase 2 Dose (RP2D) of concurrent administration of nivolumab, ipilimumab, and nintedanib. The maximum tolerated dose (MTD) is defined as the dose with the dose limiting toxicity (DLT) rate of 30%. Phase 1 began with 100 mg nintedanib, 3 mg/kg IV nivolumab + 1 mg/kg ipilimumab. Dosing of nintedanib increased by 50 mg in each level until dose limiting toxicity.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

66 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2026-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 Nintedanib Level -1: 100 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 100 mg) Nivolumab + Ipilimumab + Nintedanib Dose Escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 1 Nintedanib Level 0: 150 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 150 mg) Nivolumab + Ipilimumab + Nintedanib Dose Escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 1 Nintedanib Level 1: 100 mg by Mouth (PO) Twice Daily (BID) Days 2-28 (Daily Dose 200 mg) Nivolumab + Ipilimumab + Nintedanib Dose Escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 2 - Arm A Nintedanib 200 mg BID Treatment-naïve Arm A: Treatment-naïve defined as newly diagnosed or treatment-naïve patients, with a target overall response rate (ORR) of 50%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Phase 2- Arm B Nintedanib 200 mg BID Treatment Non-naïve Arm B: Treatment Non-naïve defined as patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.
Overall Study STARTED	3	6	5	22	30
Overall Study COMPLETED	3	6	5	22	30
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Nintedanib Level -1: 100 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 100 mg) n=3 Participants Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 1 Nintedanib Level 0: 150 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 150 mg) n=6 Participants Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 1 Nintedanib Level 1: 100 mg by Mouth (PO) Twice Daily (BID) Days 2-28 (Daily Dose 200 mg) n=5 Participants Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 2- Arm A Nintedanib 200 mg BID Treatment-naïve n=22 Participants Arm A: Treatment-naïve defined as newly diagnosed or treatment-naïve patients, with a target overall response rate (ORR) of 50%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Phase 2- Arm B Nintedanib 200 mg BID Treatment Non-naïve n=28 Participants Arm B: Treatment Non-naïve defined as patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Total n=64 Participants Total of all reporting groups
Sex: Female, Male Female	1 Participants n=270 Participants	3 Participants n=4 Participants	4 Participants n=9 Participants	12 Participants n=220 Participants	15 Participants n=3 Participants	35 Participants n=18 Participants
Age, Categorical <=18 years	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=270 Participants	3 Participants n=4 Participants	3 Participants n=9 Participants	9 Participants n=220 Participants	13 Participants n=3 Participants	29 Participants n=18 Participants
Age, Categorical >=65 years	2 Participants n=270 Participants	3 Participants n=4 Participants	2 Participants n=9 Participants	13 Participants n=220 Participants	15 Participants n=3 Participants	35 Participants n=18 Participants
Sex: Female, Male Male	2 Participants n=270 Participants	3 Participants n=4 Participants	1 Participants n=9 Participants	10 Participants n=220 Participants	13 Participants n=3 Participants	29 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	2 Participants n=3 Participants	3 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=270 Participants	6 Participants n=4 Participants	5 Participants n=9 Participants	20 Participants n=220 Participants	25 Participants n=3 Participants	58 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	2 Participants n=220 Participants	1 Participants n=3 Participants	3 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	1 Participants n=3 Participants	1 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	1 Participants n=220 Participants	2 Participants n=3 Participants	3 Participants n=18 Participants
Race (NIH/OMB) White	3 Participants n=270 Participants	6 Participants n=4 Participants	5 Participants n=9 Participants	20 Participants n=220 Participants	23 Participants n=3 Participants	57 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants	0 Participants n=3 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	1 Participants n=220 Participants	2 Participants n=3 Participants	3 Participants n=18 Participants
Region of Enrollment United States	3 participants n=270 Participants	6 participants n=4 Participants	5 participants n=9 Participants	22 participants n=220 Participants	29 participants n=3 Participants	65 participants n=18 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Phase 1 participants

Outcome measures

Outcome measures
Measure	Phase 2 - Arm B Arm B: Patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Phase 1-Dose Escalation n=14 Participants Nivolumab + Ipilimumab + Nintedanib dose escalation
Phase 1 - Maximum Tolerated Dose (MTD)	—	150 miligrams nintedanib

PRIMARY outcome

Timeframe: Up to 36 months

Population: Evaluable participants

Objective response is defined as confirmed CR or confirmed PR based on modified RECIST guidelines version 1.1. The ORR will be estimated by calculating the proportion of patients who achieve OR; the 80% Confidence Interval (CI) and 95% CI for the OR rate will be estimated using the exact binomial distribution. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Phase 2 - Arm B n=28 Participants Arm B: Patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Phase 1-Dose Escalation n=22 Participants Nivolumab + Ipilimumab + Nintedanib dose escalation
Phase 2 - Objective Response Rate (ORR) Per Treatment Arm	21.4 percentage of participants Interval 9.03 to 41.5	40.9 percentage of participants Interval 21.5 to 63.3

SECONDARY outcome

Timeframe: Up to 36 months

Population: Evaluable participants

Disease control is defined as CR, PR, or SD based on RECIST guidelines version 1.1 with modifications. The disease control rate (DCR) will be estimated by the proportion of patients who achieve DC, and its 80% CI and 95% CI will be estimated using the exact binomial distribution. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Phase 2 - Arm B n=28 Participants Arm B: Patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Phase 1-Dose Escalation n=22 Participants Nivolumab + Ipilimumab + Nintedanib dose escalation
Phase 2: Disease Control Rate (DCR)	57.1 percentage of participants Interval 37.4 to 75.0	72.7 percentage of participants Interval 49.6 to 88.4

SECONDARY outcome

Timeframe: Up to 36 months

Population: Evaluable participants

Overall survival will be determined as the time from the start of treatment with nivolumab plus ipilimumab plus nintedanib until death due to any cause. For patients who are alive at the time of data cut-off, OS will be censored on the last date when patients are known to be alive. This result is provided as number of months of survival.

Outcome measures

Outcome measures
Measure	Phase 2 - Arm B n=28 Participants Arm B: Patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Phase 1-Dose Escalation n=22 Participants Nivolumab + Ipilimumab + Nintedanib dose escalation
Phase 2: Overall Survival (OS)	8.2 months Interval 5.0 to 25.3	17.1 months Interval 5.5 to 46.9

SECONDARY outcome

Timeframe: Up to 36 months

Population: Evaluable participants

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Outcome measures

Outcome measures
Measure	Phase 2 - Arm B n=28 Participants Arm B: Patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Phase 1-Dose Escalation n=22 Participants Nivolumab + Ipilimumab + Nintedanib dose escalation
Phase 2: Progression-free Survival (PFS)	2.6 months Interval 1.4 to 6.9	5.5 months Interval 2.9 to 36.0

Adverse Events

Phase 1 Nintedanib Level -1: 100 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 100 mg)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Phase 1 Nintedanib Level 0: 150 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 150 mg)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 1 Nintedanib Level 1: 100 mg by Mouth (PO) Twice Daily (BID) Days 2-28 (Daily Dose 200 mg)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 5 deaths

Phase 2- Arm A Nintedanib 200 mg BID Treatment-naïve

Serious events: 14 serious events

Other events: 22 other events

Deaths: 19 deaths

Phase 2- Arm B Nintedanib 200 mg BID Treatment Non-naïve

Serious events: 15 serious events

Other events: 29 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 Nintedanib Level -1: 100 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 100 mg) n=3 participants at risk Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 1 Nintedanib Level 0: 150 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 150 mg) n=6 participants at risk Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 1 Nintedanib Level 1: 100 mg by Mouth (PO) Twice Daily (BID) Days 2-28 (Daily Dose 200 mg) n=5 participants at risk Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 2- Arm A Nintedanib 200 mg BID Treatment-naïve n=22 participants at risk Arm A: Treatment-naïve defined as newly diagnosed or treatment-naïve patients, with a target overall response rate (ORR) of 50%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Phase 2- Arm B Nintedanib 200 mg BID Treatment Non-naïve n=30 participants at risk Arm B: Treatment Non-naïve defined as patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)-Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Eye disorders Eye disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Vascular disorders Thromboembolic event	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.3% 4/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Colitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Sepsis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Nausea	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Encephalopathy	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Death NOS	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Lung infection	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Gait disturbance	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Autoimmune mediated hepatitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Investigations - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Non-cardiac chest pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Chills	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Paroxysmal atrial tachycardia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Vascular disorders Hypotension	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Hallucinations	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Enterocolitis infectious	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Urinary tract infection	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Renal calculi	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Intracranial hemorrhage	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Delirium	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Constipation	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Headache	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Stroke	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Confusion	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Cardiac arrest	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Injury, poisoning and procedural complications Fracture	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Appendicitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Wound infection	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.

Other adverse events

Other adverse events
Measure	Phase 1 Nintedanib Level -1: 100 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 100 mg) n=3 participants at risk Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 1 Nintedanib Level 0: 150 mg by Mouth (PO) Once a Day (QD) Days 1-14 (Daily Dose 150 mg) n=6 participants at risk Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 1 Nintedanib Level 1: 100 mg by Mouth (PO) Twice Daily (BID) Days 2-28 (Daily Dose 200 mg) n=5 participants at risk Nivolumab + Ipilimumab + Nintedanib dose escalation. Participants were given a fixed dose of Nivolumab 3 mg/kg IV every 2 weeks, a fixed dose of Ipilimumab 1 mg/kg every 6 weeks, and escalating doses of Nintedanib starting at 100mg PO once daily (five dose levels) to determine the Maximum Tolerated Dose (MTD).	Phase 2- Arm A Nintedanib 200 mg BID Treatment-naïve n=22 participants at risk Arm A: Treatment-naïve defined as newly diagnosed or treatment-naïve patients, with a target overall response rate (ORR) of 50%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.	Phase 2- Arm B Nintedanib 200 mg BID Treatment Non-naïve n=30 participants at risk Arm B: Treatment Non-naïve defined as patients who have been previously exposed to immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4, with a target ORR of 20%. Participants were given the following: Nivolumab + Ipilimumab + Nintedanib at RP2D. Nivolumab: Intravenous nivolumab every 2 weeks. Ipilimumab: Intravenous ipilimumab every 6 weeks. Nintedanib: Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.
Gastrointestinal disorders Proctitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Stomach pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	60.0% 3/5 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	22.7% 5/22 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	26.7% 8/30 • Number of events 9 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	27.3% 6/22 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 5/30 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Fatigue	66.7% 2/3 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	100.0% 6/6 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	54.5% 12/22 • Number of events 16 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	53.3% 16/30 • Number of events 19 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	31.8% 7/22 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 5/30 • Number of events 11 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Pain	33.3% 1/3 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	50.0% 3/6 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	27.3% 6/22 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Fever	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	27.3% 6/22 • Number of events 9 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 5/30 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Edema Limbs	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	22.7% 5/22 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Non-cardiac chest pain	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Chills	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Flu like symptoms	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Infusion related reaction	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Gait disturbance	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Edema face	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Hypothermia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Localized edema	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Malise	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Multi-organ failure	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Nausea	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	50.0% 3/6 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	63.6% 14/22 • Number of events 26 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	53.3% 16/30 • Number of events 30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	83.3% 5/6 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	63.6% 14/22 • Number of events 25 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 12/30 • Number of events 26 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Constipation	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	27.3% 6/22 • Number of events 9 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	23.3% 7/30 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	50.0% 3/6 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	30.0% 9/30 • Number of events 15 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	27.3% 6/22 • Number of events 12 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	23.3% 7/30 • Number of events 9 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	50.0% 3/6 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	18.2% 4/22 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
General disorders Colitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Gastritis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Bloating	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Esophagitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Toothache	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Ascites	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	66.7% 4/6 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.9% 9/22 • Number of events 12 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	43.3% 13/30 • Number of events 17 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	23.3% 7/30 • Number of events 23 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	18.2% 4/22 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	50.0% 3/6 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	60.0% 3/5 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	18.2% 4/22 • Number of events 10 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	23.3% 7/30 • Number of events 9 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Investigations - Other, specify	33.3% 1/3 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	66.7% 4/6 • Number of events 10 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	60.0% 3/5 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	22.7% 5/22 • Number of events 9 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 5/30 • Number of events 11 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	50.0% 3/6 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	60.0% 3/5 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 12 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	23.3% 7/30 • Number of events 11 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Weight loss	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.3% 4/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Alkaline phosphatase increased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Neutrophil count decreased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Creatinine increased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Lymphocyte count decreased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Platelet count decreased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Weight gain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations White blood cell decreased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Blood bilirubin increased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Cardiac troponin T increased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations Hemoglobin increased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Investigations INR increased	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	50.0% 3/6 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	18.2% 4/22 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 6/30 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	33.3% 1/3 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Arthritis	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Buttock pain	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Headache	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	27.3% 6/22 • Number of events 13 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 5/30 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Dizziness	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.3% 4/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Tremor	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Memory impairment	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Dysgeusia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Encephalopathy	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Ataxia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Central nervous system necrosis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Cognitive disturbance	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Edema cerebral	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Lethargy	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Stroke	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Syncope	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Amnesia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Dysarthria	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Facial muscle weakness	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Movements involuntary	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Paresthesia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Seizure	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Somnolence	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	27.3% 6/22 • Number of events 11 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	26.7% 8/30 • Number of events 13 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.3% 4/30 • Number of events 9 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	22.7% 5/22 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	22.7% 5/22 • Number of events 14 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Alopecia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Nervous system disorders Scalp pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	27.3% 6/22 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 5/30 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Urinary tract infection	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	40.0% 2/5 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 7 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Lung infection	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.3% 4/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Sepsis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Sinusitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Wound infection	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Appendicitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Laryngitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Otitis externa	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Papulopustular rash	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Paronychia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Pharyngitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Infections and infestations Small intestine infection	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Insomnia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	18.2% 4/22 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.3% 4/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Anxiety	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	50.0% 3/6 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Confusion	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Depression	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Delirium	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Vascular disorders Thromboembolic event	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.3% 4/30 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Vascular disorders Hypotension	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Vascular disorders Hypertension	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.6% 3/22 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Vascular disorders Flushing	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Vascular disorders Hot flashes	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Vascular disorders Phlebitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	18.2% 4/22 • Number of events 6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 6/30 • Number of events 21 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Chest pain - cardiac	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Myocardial infarction	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Myocarditis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Palpitations	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Pericardial effusion	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Pericarditis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 5/30 • Number of events 8 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Injury, poisoning and procedural complications Fracture	33.3% 1/3 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Injury, poisoning and procedural complications Bruising	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Eye disorders Blurred vision	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Eye disorders Eye disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	13.3% 4/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Eye disorders Uveitis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	20.0% 1/5 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	9.1% 2/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Hematuria	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Renal calculi	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Urinary frequency	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Urinary urgency	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Renal and urinary disorders Urine discoloration	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	6.7% 2/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	33.3% 2/6 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Endocrine disorders Hyperthyroidism	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	16.7% 1/6 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	10.0% 3/30 • Number of events 4 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Ear and labyrinth disorders Hearing impaired	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	4.5% 1/22 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/30 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 2 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Immune system disorders Allergic reaction	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Immune system disorders Anaphylaxis	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Immune system disorders Autoimmune disorder	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/3 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/6 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/5 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	0.00% 0/22 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.	3.3% 1/30 • Number of events 1 • Adverse Events were collected from start of Study Treatment to 100 days from end of treatment. Approximately 57 Months.

Additional Information

Dr. Jhanelle E. Gray

Moffitt Cancer Center

Phone: 813-745-7282

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place