Trial Outcomes & Findings for Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Participants With Solid Tumors (NCT NCT01862328)

NCT ID: NCT01862328

Last Updated: 2020-06-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 64 participants
• Primary outcome timeframe: Baseline up to 30 days after the last dose of study drug (up to 5 years)
• Results posted on: 2020-06-22

Participant Flow

Participants took part in the study at 6 investigative sites in the United States from 10 June 2013 to 21 May 2018.

Participants with solid tumors were enrolled to receive MLN4924 in combination with docetaxel (Arm 1), paclitaxel + carboplatin (Arm 2), or gemcitabine (Arm 3) during the Dose-escalation and maximum tolerated dose (MTD) expansion portion of this study. Participants in Lead-in cohort received MLN4924 + carboplatin only (Arm 2a).

Participant milestones

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or progressive disease (PD) (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Overall Study STARTED	4	18	6	7	12	7	10
Overall Study COMPLETED	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	18	6	7	12	7	10

Reasons for withdrawal

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or progressive disease (PD) (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Overall Study Progressive Disease	3	11	5	6	7	4	3
Overall Study Adverse Event	0	4	0	1	0	2	4
Overall Study Other	0	2	1	0	4	0	1
Overall Study Withdrawal by Subject	1	1	0	0	1	1	1
Overall Study Symptomatic Deterioration	0	0	0	0	0	0	1

Baseline Characteristics

Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Participants With Solid Tumors

Baseline characteristics by cohort

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 n=4 Participants MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=18 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 n=6 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=12 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 n=10 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Total n=64 Participants Total of all reporting groups
Age, Continuous	57.8 years STANDARD_DEVIATION 2.99 • n=5 Participants	60.0 years STANDARD_DEVIATION 9.82 • n=7 Participants	56.8 years STANDARD_DEVIATION 9.56 • n=5 Participants	58.1 years STANDARD_DEVIATION 10.65 • n=4 Participants	57.9 years STANDARD_DEVIATION 14.34 • n=21 Participants	59.0 years STANDARD_DEVIATION 12.00 • n=10 Participants	59.7 years STANDARD_DEVIATION 14.45 • n=115 Participants	58.8 years STANDARD_DEVIATION 11.19 • n=6 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants	34 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	30 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	11 Participants n=21 Participants	7 Participants n=10 Participants	7 Participants n=115 Participants	55 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	7 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	12 Participants n=6 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	13 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	11 Participants n=21 Participants	7 Participants n=10 Participants	9 Participants n=115 Participants	52 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Region of Enrollment United States	4 Participants n=5 Participants	18 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	12 Participants n=21 Participants	7 Participants n=10 Participants	10 Participants n=115 Participants	64 Participants n=6 Participants
Body surface area (BSA)	1.9 square meter (m^2) STANDARD_DEVIATION 0.32 • n=5 Participants	1.9 square meter (m^2) STANDARD_DEVIATION 0.28 • n=7 Participants	1.8 square meter (m^2) STANDARD_DEVIATION 0.29 • n=5 Participants	2.0 square meter (m^2) STANDARD_DEVIATION 0.28 • n=4 Participants	1.9 square meter (m^2) STANDARD_DEVIATION 0.32 • n=21 Participants	1.9 square meter (m^2) STANDARD_DEVIATION 0.17 • n=10 Participants	1.9 square meter (m^2) STANDARD_DEVIATION 0.25 • n=115 Participants	1.9 square meter (m^2) STANDARD_DEVIATION 0.27 • n=6 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days after the last dose of study drug (up to 5 years)

Population: The safety population was defined as all participants who received at least 1 dose of any study drug.

Outcome measures

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 n=4 Participants MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=18 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 n=6 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=12 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 n=10 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE	4 Participants	18 Participants	6 Participants	7 Participants	12 Participants	7 Participants	10 Participants
Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAE	1 Participants	9 Participants	3 Participants	2 Participants	3 Participants	1 Participants	7 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days after the last dose of study drug (up to 5 years)

Population: The safety population was defined as all participants who received at least 1 dose of any study drug.

Outcome measures

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 n=4 Participants MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=18 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 n=6 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=12 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 n=10 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Red blood cell count decreased	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Blood alkaline phosphatase increased	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Lymphocyte count decreased	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Blood bilirubin increased	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Hypophosphataemia	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Hypokalaemia	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Gamma-glutamyltransferase increased	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Blood glucose increased	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Liver function test abnormal	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Haematocrit decreased	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Anaemia	1 Participants	4 Participants	2 Participants	2 Participants	7 Participants	2 Participants	3 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Aspartate aminotransferase increased	0 Participants	6 Participants	2 Participants	2 Participants	5 Participants	2 Participants	2 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Alanine aminotransferase increased	0 Participants	7 Participants	1 Participants	1 Participants	4 Participants	1 Participants	3 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Neutrophil count decreased	1 Participants	5 Participants	1 Participants	3 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Neutropenia	1 Participants	1 Participants	1 Participants	1 Participants	4 Participants	4 Participants	3 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Thrombocytopenia	0 Participants	1 Participants	3 Participants	1 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Platelet count decreased	0 Participants	1 Participants	2 Participants	3 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings White blood cell count decreased	1 Participants	2 Participants	0 Participants	0 Participants	4 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Hypomagnesaemia	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Blood creatinine increased	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Hypoglycaemia	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Hyponatraemia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days after the last dose of study drug (up to 5 years)

Population: The safety population was defined as all participants who received at least 1 dose of any study drug.

Outcome measures

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 n=4 Participants MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=18 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 n=6 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=12 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 n=10 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings Tachycardia	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings Hypotension	1 Participants	3 Participants	2 Participants	2 Participants	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Screening, Cycle 2 Days 15 (Arm 1, 2a, and 2) and 22 (Arm 3) then every other Cycle thereafter up to 30 days after the last dose of study drug (up to 5 years) (Cycle Length = 21 days [Arm 1, 2a, and 2] and 28 days [Arm 3])

Population: The response-evaluable population was defined as all the participants who received at least 1 dose of MLN4924, had measurable disease at baseline, and had at least 1 post baseline disease assessment.

Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]); no new lesions. PR: greater than or equal to (>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions; short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.

Outcome measures

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 n=3 Participants MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=16 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 n=6 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=11 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=5 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 n=6 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Percentage of Participants With Objective Response CR	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	18 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Objective Response PR	0 percentage of participants	19 percentage of participants	17 percentage of participants	0 percentage of participants	36 percentage of participants	40 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From the date of first documented response (CR or PR) to the date of first documented PD or the date of last disease assessment if the participants discontinued the study before PD (up to 5 years)

Population: The response-evaluable population is defined as all participants who receive at least 1 dose of study drug, have measurable disease at baseline, and have at least 1 post baseline disease assessment. The number of participants analyzed includes only those participants who had data available for this measure.

Duration of response: time from the date of first documented response per the investigator response assessment (CR or PR) to the date of PD or the date of last disease assessment if the participant discontinued the study before PD using RECIST 1.1 CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: >=30% decrease under baseline of sum of diameters of all target lesions; short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in sum of diameters of target lesions, taking as reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Outcome measures

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=3 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 n=1 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=2 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Duration of Response	—	2.880 months Standard Deviation 2.7644	2.270 months Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.	—	16.153 months Standard Deviation 15.9867	7.015 months Standard Deviation 1.1384	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 20 hours) post-dose (Cycle Length=21 days [Arm 1 and 2] and 28 days [Arm 3])

Population: The safety population was defined as all participants who received at least 1 dose of any study drug. The number of participants analyzed includes only those participants who had data available for this measure. This outcome measure was planned to be assessed only in the Dose-escalation phases of Arms 1, 2, and 3.

Outcome measures

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 n=4 Participants MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=18 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 n=7 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 n=12 Participants MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=7 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=10 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Dose-escalation Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: 3 hours post dose	48.0 nanogram per milliliter (ng/ml) Standard Deviation 12.05	95.8 nanogram per milliliter (ng/ml) Standard Deviation 19.70	152.4 nanogram per milliliter (ng/ml) Standard Deviation 56.19	138.0 nanogram per milliliter (ng/ml) Standard Deviation 73.10	186.9 nanogram per milliliter (ng/ml) Standard Deviation 32.30	103.0 nanogram per milliliter (ng/ml) Standard Deviation 39.00	—
Dose-escalation Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: End-dose	163.8 nanogram per milliliter (ng/ml) Standard Deviation 109.15	197.1 nanogram per milliliter (ng/ml) Standard Deviation 51.94	275.7 nanogram per milliliter (ng/ml) Standard Deviation 98.67	257.3 nanogram per milliliter (ng/ml) Standard Deviation 110.05	372.7 nanogram per milliliter (ng/ml) Standard Deviation 120.93	222.0 nanogram per milliliter (ng/ml) Standard Deviation 87.62	—
Dose-escalation Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: 1.5 hours post dose	82.0 nanogram per milliliter (ng/ml) Standard Deviation 39.97	130.6 nanogram per milliliter (ng/ml) Standard Deviation 46.94	156.8 nanogram per milliliter (ng/ml) Standard Deviation 53.46	192.7 nanogram per milliliter (ng/ml) Standard Deviation 80.35	246.7 nanogram per milliliter (ng/ml) Standard Deviation 47.24	160.5 nanogram per milliliter (ng/ml) Standard Deviation 122.07	—
Dose-escalation Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: 20 hours post dose	7.5 nanogram per milliliter (ng/ml) Standard Deviation 1.50	14.6 nanogram per milliliter (ng/ml) Standard Deviation 4.81	23.4 nanogram per milliliter (ng/ml) Standard Deviation 9.19	34.6 nanogram per milliliter (ng/ml) Standard Deviation 25.09	24.4 nanogram per milliliter (ng/ml) Standard Deviation 10.81	14.2 nanogram per milliliter (ng/ml) Standard Deviation 5.09	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 5 pre-dose and at multiple time points (up to 20 hours) post-dose (Cycle Length=21 days [Arm 1 and 2])

Population: The safety population was defined as all participants who received at least 1 dose of any study drug. This outcome measure was planned to be assessed for participants who received the MTD in Arms 1 and 2.

The number of participants analyzed includes only those participants who had data available for this measure.

Outcome measures

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 n=18 Participants MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=12 Participants MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: End-dose	152.8 ng/ml Standard Deviation 83.67	429.8 ng/ml Standard Deviation 95.87	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: 1.5 hours post dose	137.3 ng/ml Standard Deviation 37.19	253.6 ng/ml Standard Deviation 19.65	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: 3 hours post dose	86.4 ng/ml Standard Deviation 29.16	192.8 ng/ml Standard Deviation 39.14	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: 6 hours post dose	—	136.3 ng/ml Standard Deviation 14.73	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: 7 hours post dose	63.4 ng/ml Standard Deviation 24.87	—	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 1: 20 hours post dose	14.2 ng/ml Standard Deviation 5.39	30.2 ng/ml Standard Deviation 7.98	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 5: End-dose	211.1 ng/ml Standard Deviation 116.43	253.2 ng/ml Standard Deviation 56.60	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 5: 1.5 hours post dose	115.3 ng/ml Standard Deviation 42.54	171.0 ng/ml Standard Deviation 19.44	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 5: 3 hours post dose	96.7 ng/ml Standard Deviation 53.48	118.4 ng/ml Standard Deviation 19.69	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 5: 6 hours post dose	—	76.5 ng/ml Standard Deviation 4.97	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 5: 7 hours post dose	38.3 ng/ml Standard Deviation 17.84	—	—	—	—	—	—
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924 Cycle 1 Day 5: 20 hours post dose	9.8 ng/ml Standard Deviation 2.07	10.9 ng/ml Standard Deviation 3.40	—	—	—	—	—

Adverse Events

Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2

Serious events: 9 serious events

Other events: 18 other events

Deaths: 2 deaths

Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5

Serious events: 1 serious events

Other events: 7 other events

Deaths: 1 deaths

Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2

Serious events: 7 serious events

Other events: 10 other events

Deaths: 3 deaths

Serious adverse events

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 n=4 participants at risk MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=18 participants at risk MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 n=6 participants at risk MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 n=7 participants at risk MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=12 participants at risk MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=7 participants at risk MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 n=10 participants at risk MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 2/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Acute coronary syndrome	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Death	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Influenza	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bacteraemia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sepsis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Septic shock	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Electrocardiogram ST segment depression	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Liver function test increased	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Neutrophil count decreased	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Encephalopathy	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Seizure	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypotension	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2 n=4 participants at risk MLN4924 15 milligram per square meter (mg/m\^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2 n=18 participants at risk MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m\^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6 n=6 participants at risk MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5 n=7 participants at risk MLN4924 15 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=12 participants at risk MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5 n=7 participants at risk MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m\^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).	Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2 n=10 participants at risk MLN4924 25 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m\^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 6/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 8/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	40.0% 4/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 3/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.0% 3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 4/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	57.1% 4/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 2/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Leukopenia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 2/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 2/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Tachycardia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Vision blurred	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Lacrimation increased	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	44.4% 8/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	83.3% 5/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 8/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 5/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Constipation	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	41.7% 5/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.0% 3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	75.0% 3/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 6/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	57.1% 4/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 6/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 4/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 6/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.0% 3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 4/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	27.8% 5/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	61.1% 11/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	66.7% 4/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	71.4% 5/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	58.3% 7/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	71.4% 5/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	40.0% 4/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 4/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 2/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Oedema peripheral	50.0% 2/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.0% 3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Asthenia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 3/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Chills	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Non-cardiac chest pain	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Urinary tract infection	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 4/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	50.0% 2/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Cellulitis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Contusion	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 6/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	41.7% 5/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.0% 3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	38.9% 7/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 4/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	40.0% 4/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Neutrophil count decreased	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 4/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 3/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Platelet count decreased	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.0% 3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations White blood cell count decreased	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	41.7% 5/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 4/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood creatinine increased	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight increased	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 3/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood bilirubin increased	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Lymphocyte count decreased	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Decreased appetite	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 3/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 5/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypokalaemia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 4/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyponatraemia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperglycaemia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 3/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	57.1% 4/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 2/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 6/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 4/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 4/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 2/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Neuropathy peripheral	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	41.7% 5/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dysgeusia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dysarthria	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	50.0% 2/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	50.0% 3/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.0% 3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	75.0% 3/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	30.0% 3/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	25.0% 3/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	22.2% 4/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	41.7% 5/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	20.0% 2/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dry skin	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Nail discolouration	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.6% 1/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Flushing	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 3/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	42.9% 3/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypotension	25.0% 1/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.1% 2/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Extrasystoles	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Eye irritation	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Visual impairment	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Oral pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Chest discomfort	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Chest pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Localised oedema	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Malaise	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Epididymitis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hypophagia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Paraesthesia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Syncope	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness postural	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Anxiety	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	33.3% 2/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Dysuria	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Micturition urgency	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Testicular appendage torsion	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 1/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Oral candidiasis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Agitation	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Haematuria	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	14.3% 1/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.3% 1/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hypertension	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 2/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 2/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Ascites	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Oedema	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Immune system disorders Multiple allergies	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sepsis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Gout	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Sciatica	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Uraemic encephalopathy	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Confusional state	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hot flush	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Platelet count increased	0.00% 0/4 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/18 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/6 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/12 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/7 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	10.0% 1/10 • TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
• Publication restrictions are in place

Restriction type: OTHER