Trial Outcomes & Findings for A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma (NCT NCT01992653)

NCT ID: NCT01992653

Last Updated: 2023-03-14

Results Overview

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

85 participants

Primary outcome timeframe

Baseline up to 5 years

Results posted on

2023-03-14

Participant Flow

The study was conducted at 11 centers in 2 countries.

A total of 85 participants were enrolled at 11 centers in the following countries: France (31 participants) and United States (54 participants). 3 participants did not receive any study treatment (2 had exclusionary lab values and 1 withdrew) meaning that the safety population consisted of 82 participants.

Participant milestones

Participant milestones
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Study STARTED	3	3	6	1	6	6	40	17
Overall Study COMPLETED	3	3	5	1	5	6	32	13
Overall Study NOT COMPLETED	0	0	1	0	1	0	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Polatuzumab Vedotin (1.8mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Study Death	1	1	4	2
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Study Completed	0	0	0	1
Overall Study Disease Progression	0	0	4	0

Baseline Characteristics

A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.	Total n=82 Participants Total of all reporting groups
Age, Continuous	67.3 Years STANDARD_DEVIATION 6.4 • n=5 Participants	65.0 Years STANDARD_DEVIATION 7.0 • n=7 Participants	67.3 Years STANDARD_DEVIATION 3.5 • n=5 Participants	68.0 Years STANDARD_DEVIATION NA • n=4 Participants	70.7 Years STANDARD_DEVIATION 4.5 • n=21 Participants	60.0 Years STANDARD_DEVIATION 14.3 • n=10 Participants	69.6 Years STANDARD_DEVIATION 7.2 • n=115 Participants	61.6 Years STANDARD_DEVIATION 14.6 • n=24 Participants	66.9 Years STANDARD_DEVIATION 9.9 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	20 Participants n=115 Participants	6 Participants n=24 Participants	39 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=10 Participants	20 Participants n=115 Participants	11 Participants n=24 Participants	43 Participants n=42 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	27 Participants n=115 Participants	14 Participants n=24 Participants	66 Participants n=42 Participants
Race/Ethnicity, Customized Not Stated	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	9 Participants n=115 Participants	3 Participants n=24 Participants	12 Participants n=42 Participants
Race/Ethnicity, Customized Unknown	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	3 Participants n=115 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Other	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	4 Participants n=115 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	33 Participants n=115 Participants	15 Participants n=24 Participants	72 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=5 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population	2 Participants	3 Participants	5 Participants	0 Participants	4 Participants	4 Participants	40 Participants	17 Participants

PRIMARY outcome

Timeframe: Baseline up to 5 years

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Number of Participants With Adverse Events in Non-DLBCL Population	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.

All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=5 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Number of Participants With DLTs in Non-DLBCL Population	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At the end of treatment (Month 6)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.

Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=5 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population Complete Response (CR)	50.0 Percentage of Participants Interval 2.53 to 97.47	100.0 Percentage of Participants Interval 36.84 to 100.0	100.0 Percentage of Participants Interval 54.93 to 100.0	—	75.0 Percentage of Participants Interval 24.86 to 98.73	100.0 Percentage of Participants Interval 47.29 to 100.0	75.0 Percentage of Participants Interval 61.29 to 85.76	76.5 Percentage of Participants Interval 53.95 to 91.54
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population Partial Response (PR)	50.0 Percentage of Participants Interval 2.53 to 97.47	0 Percentage of Participants Interval 0.0 to 63.16	0 Percentage of Participants Interval 0.0 to 45.07	—	0 Percentage of Participants Interval 0.0 to 52.71	0 Percentage of Participants Interval 0.0 to 52.71	15.0 Percentage of Participants Interval 6.74 to 27.47	11.8 Percentage of Participants Interval 2.13 to 32.62

SECONDARY outcome

Timeframe: At the end of treatment (Month 6)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population Complete Response (CR)	100.0 Percentage of Participants Interval 5.0 to 100.0	—	100.0 Percentage of Participants Interval 5.0 to 100.0	100.0 Percentage of Participants Interval 5.0 to 100.0	100.0 Percentage of Participants Interval 22.36 to 100.0	100.0 Percentage of Participants Interval 22.36 to 100.0	—	—
Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population Partial Response (PR)	0 Percentage of Participants Interval 0.0 to 95.0	—	0 Percentage of Participants Interval 0.0 to 95.0	0 Percentage of Participants Interval 0.0 to 95.0	0 Percentage of Participants Interval 0.0 to 77.64	0 Percentage of Participants Interval 0.0 to 77.64	—	—

SECONDARY outcome

Timeframe: Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.

The Anti-Drug Antibody (ADA) screening assay was optimized to tolerate drug interference and was able to detect 90 and 500 ng/mL of the positive control sample in the presence of 20 μg/mL of polatuzumab vedotin. Polatuzumab vedotin total antibody concentrations were determined for each ADA sample. Out of a total of 186 ADA samples that were measured for polatuzumab vedotin total antibody, 184 samples had levels less than 20 μg/mL. Polatuzumab vedotin total antibody concentrations ranged from \<0.050 μg/mL to 52.1 μg/mL with a median concentration of 3.38 μg/mL.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Number of Participants With Anti-Polatuzumab Vedotin Antibodies	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.

The ADA screening assay was optimized to tolerate drug interference and was able to detect 500 ng/mL of the ADA-positive control sample in the presence of 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations were determined for each ADA sample. Out of a total of 48 ADA samples that were measured for obinutuzumab, 9 samples had levels less than 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations in ADA samples ranged from 0.282 micrograms/mL to 522 micrograms/mL with a median concentration of 210 micrograms/mL. Therefore, it is possible that samples with obinutuzumab concentrations greater than 50 micrograms/mL might be false negative for ADA.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Number of Participants With Anti-Obinutuzumab Antibodies	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.

AUC information for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin	1300 ng day/mL Standard Deviation 22	1510 ng day/mL Standard Deviation 354	2600 ng day/mL Standard Deviation 413	4090 ng day/mL Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.	1940 ng day/mL Standard Deviation 154	1850 ng day/mL Standard Deviation 491	1870 ng day/mL Standard Deviation 527	1940 ng day/mL Standard Deviation 482

SECONDARY outcome

Timeframe: Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.

Cmax for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Maximum Concentration (Cmax) of Polatuzumab Vedotin	373 ng/mL Standard Deviation 147	537 ng/mL Standard Deviation 184	781 ng/mL Standard Deviation 72.6	1400 ng/mL Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.	537 ng/mL Standard Deviation 59.1	557 ng/mL Standard Deviation 114	532 ng/mL Standard Deviation 163	530 ng/mL Standard Deviation 138

SECONDARY outcome

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.

CL for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Clearance (CL) of Polatuzumab Vedotin	14.0 mL/day/kg Standard Deviation 0.370	17.3 mL/day/kg Standard Deviation 4.16	12.8 mL/day/kg Standard Deviation 2.05	10.5 mL/day/kg Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.	13.2 mL/day/kg Standard Deviation 1.29	18.7 mL/day/kg Standard Deviation 5.30	18.9 mL/day/kg Standard Deviation 5.27	17.7 mL/day/kg Standard Deviation 3.83

SECONDARY outcome

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.

t1/2 for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Terminal Half-Life (t1/2) of Polatuzumab Vedotin	5.03 days Standard Deviation 0.905	4.85 days Standard Deviation 0.720	4.79 days Standard Deviation 0.675	4.42 days Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.	5.19 days Standard Deviation 0.430	4.89 days Standard Deviation 0.526	5.03 days Standard Deviation 0.621	5.50 days Standard Deviation 0.795

SECONDARY outcome

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.

Vss for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin	58.2 mL/kg Standard Deviation 9.92	80.0 mL/kg Standard Deviation 9.97	57.7 mL/kg Standard Deviation 7.95	41.9 mL/kg Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.	67.9 mL/kg Standard Deviation 7.42	87.5 mL/kg Standard Deviation 19.3	96.5 mL/kg Standard Deviation 34.1	99.3 mL/kg Standard Deviation 27.4

SECONDARY outcome

Timeframe: End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of cyclophosphamide were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.

Plasma levels of cyclophosphamide will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Plasma Levels of Cyclophosphamide C1D1 0.5hr POSTDOSE	—	—	—	—	—	—	37.5 ug/mL Standard Deviation 24.4	32.3 ug/mL Standard Deviation 7.64
Plasma Levels of Cyclophosphamide C1D1 3.5hr POSTDOSE	—	—	—	—	—	—	23.2 ug/mL Standard Deviation 2.38	22.5 ug/mL Standard Deviation 3.69
Plasma Levels of Cyclophosphamide C1D1 23.5hr POSTDOSE	—	—	—	—	—	—	2.98 ug/mL Standard Deviation 1.39	3.32 ug/mL Standard Deviation 1.50
Plasma Levels of Cyclophosphamide C3D1 0.5hr POSTDOSE	—	—	—	—	—	—	34.8 ug/mL Standard Deviation 6.14	35.2 ug/mL Standard Deviation 13.4
Plasma Levels of Cyclophosphamide C3D1 3.5hr POSTDOSE	—	—	—	—	—	—	24.2 ug/mL Standard Deviation 3.87	22.5 ug/mL Standard Deviation 4.26
Plasma Levels of Cyclophosphamide C3D1 23.5hr POSTDOSE	—	—	—	—	—	—	3.17 ug/mL Standard Deviation 1.66	3.16 ug/mL Standard Deviation 1.68

SECONDARY outcome

Timeframe: 2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of doxorubicin were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.

Plasma levels of doxorubicin will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Plasma Levels of Doxorubicin C1D1 2hr POSTDOSE	—	—	—	—	—	—	35.4 ug/mL Standard Deviation 13.6	30.2 ug/mL Standard Deviation 6.82
Plasma Levels of Doxorubicin C1D1 24hr POSTDOSE	—	—	—	—	—	—	9.13 ug/mL Standard Deviation 2.51	11.7 ug/mL Standard Deviation 11.6
Plasma Levels of Doxorubicin C3D1 2hr POSTDOSE	—	—	—	—	—	—	29.3 ug/mL Standard Deviation 10.9	29.6 ug/mL Standard Deviation 10.8
Plasma Levels of Doxorubicin C3D1 24hr POSTDOSE	—	—	—	—	—	—	8.68 ug/mL Standard Deviation 2.05	9.14 ug/mL Standard Deviation 2.12

SECONDARY outcome

Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.

Population: The safety population was defined as all participants who have received at least one dose of study medication. TINAS was only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.

The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 18	—	—	—	—	—	—	—	0.64 Score of a Questionnaire Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Baseline	—	—	—	—	—	—	0 Score of a Questionnaire Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.	0.32 Score of a Questionnaire Standard Deviation 0.45
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 1	—	—	—	—	—	—	0 Score of a Questionnaire Standard Deviation 0	0.91 Score of a Questionnaire Standard Deviation 0.92
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 2	—	—	—	—	—	—	0.02 Score of a Questionnaire Standard Deviation 0.04	0.07 Score of a Questionnaire Standard Deviation 0.16
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 3	—	—	—	—	—	—	0.06 Score of a Questionnaire Standard Deviation 0.10	0.22 Score of a Questionnaire Standard Deviation 0.44
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 4	—	—	—	—	—	—	0.18 Score of a Questionnaire Standard Deviation 0.36	0.26 Score of a Questionnaire Standard Deviation 0.63
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 5	—	—	—	—	—	—	0.16 Score of a Questionnaire Standard Deviation 0.32	0.17 Score of a Questionnaire Standard Deviation 0.41
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 6	—	—	—	—	—	—	0.16 Score of a Questionnaire Standard Deviation 0.32	0.25 Score of a Questionnaire Standard Deviation 0.57
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 7	—	—	—	—	—	—	0.14 Score of a Questionnaire Standard Deviation 0.28	0.35 Score of a Questionnaire Standard Deviation 0.77
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 8	—	—	—	—	—	—	0.17 Score of a Questionnaire Standard Deviation 0.37	0.31 Score of a Questionnaire Standard Deviation 0.59
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 9	—	—	—	—	—	—	0.25 Score of a Questionnaire Standard Deviation 0.47	0.38 Score of a Questionnaire Standard Deviation 0.61
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 10	—	—	—	—	—	—	0.30 Score of a Questionnaire Standard Deviation 0.41	0.53 Score of a Questionnaire Standard Deviation 0.71
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 11	—	—	—	—	—	—	0.26 Score of a Questionnaire Standard Deviation 0.35	0.39 Score of a Questionnaire Standard Deviation 0.73
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 12	—	—	—	—	—	—	0.30 Score of a Questionnaire Standard Deviation 0.43	0.65 Score of a Questionnaire Standard Deviation 1.02
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 13	—	—	—	—	—	—	0.25 Score of a Questionnaire Standard Deviation 0.32	0.78 Score of a Questionnaire Standard Deviation 1.34
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 14	—	—	—	—	—	—	0.49 Score of a Questionnaire Standard Deviation 0.86	0.62 Score of a Questionnaire Standard Deviation 1.05
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 15	—	—	—	—	—	—	0.48 Score of a Questionnaire Standard Deviation 0.86	0.70 Score of a Questionnaire Standard Deviation 1.28
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 16	—	—	—	—	—	—	0.66 Score of a Questionnaire Standard Deviation 0.94	1.12 Score of a Questionnaire Standard Deviation 1.61
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 17	—	—	—	—	—	—	0.25 Score of a Questionnaire Standard Deviation 0.52	0.91 Score of a Questionnaire Standard Deviation 1.44
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 19	—	—	—	—	—	—	—	0.45 Score of a Questionnaire Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.
Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score Week 22	—	—	—	—	—	—	—	0.09 Score of a Questionnaire Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.

SECONDARY outcome

Timeframe: Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.

The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Baseline	—	—	—	—	—	—	0 Score of a Questionnaire Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.	0 Score of a Questionnaire Standard Deviation 0
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 1	—	—	—	—	—	—	0 Score of a Questionnaire Standard Deviation 0	1 Score of a Questionnaire Standard Deviation 1.73
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 2	—	—	—	—	—	—	0.25 Score of a Questionnaire Standard Deviation 0.50	0 Score of a Questionnaire Standard Deviation 0
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 3	—	—	—	—	—	—	0.33 Score of a Questionnaire Standard Deviation 0.58	0.40 Score of a Questionnaire Standard Deviation 0.89
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 4	—	—	—	—	—	—	0.40 Score of a Questionnaire Standard Deviation 0.55	0.50 Score of a Questionnaire Standard Deviation 1.22
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 5	—	—	—	—	—	—	0.40 Score of a Questionnaire Standard Deviation 0.55	0.17 Score of a Questionnaire Standard Deviation 0.41
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 6	—	—	—	—	—	—	0.40 Score of a Questionnaire Standard Deviation 0.55	0.40 Score of a Questionnaire Standard Deviation 0.89
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 7	—	—	—	—	—	—	0.29 Score of a Questionnaire Standard Deviation 0.49	0.60 Score of a Questionnaire Standard Deviation 1.34
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 8	—	—	—	—	—	—	0.33 Score of a Questionnaire Standard Deviation 0.52	0.25 Score of a Questionnaire Standard Deviation 0.71
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 9	—	—	—	—	—	—	0.40 Score of a Questionnaire Standard Deviation 0.55	0.50 Score of a Questionnaire Standard Deviation 1.07
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 10	—	—	—	—	—	—	0.86 Score of a Questionnaire Standard Deviation 1.21	1.14 Score of a Questionnaire Standard Deviation 1.46
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 11	—	—	—	—	—	—	0.86 Score of a Questionnaire Standard Deviation 1.21	0.57 Score of a Questionnaire Standard Deviation 1.13
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 12	—	—	—	—	—	—	1.14 Score of a Questionnaire Standard Deviation 1.21	0.71 Score of a Questionnaire Standard Deviation 1.25
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 13	—	—	—	—	—	—	0.86 Score of a Questionnaire Standard Deviation 1.21	1.12 Score of a Questionnaire Standard Deviation 1.81
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 14	—	—	—	—	—	—	1.12 Score of a Questionnaire Standard Deviation 1.73	0.88 Score of a Questionnaire Standard Deviation 1.36
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 15	—	—	—	—	—	—	1.12 Score of a Questionnaire Standard Deviation 1.73	0.75 Score of a Questionnaire Standard Deviation 1.16
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 16	—	—	—	—	—	—	1.56 Score of a Questionnaire Standard Deviation 2.07	1.50 Score of a Questionnaire Standard Deviation 1.69
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 17	—	—	—	—	—	—	0.40 Score of a Questionnaire Standard Deviation 0.55	1.14 Score of a Questionnaire Standard Deviation 1.46
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 18	—	—	—	—	—	—	—	2 Score of a Questionnaire Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 19	—	—	—	—	—	—	—	2 Score of a Questionnaire Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.
Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score Week 22	—	—	—	—	—	—	—	1 Score of a Questionnaire Standard Deviation NA Due to there being only 1 participant in this group, the SD could not be estimated.

SECONDARY outcome

Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.

Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=5 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Interval 14.03 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Interval 27.93 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.

SECONDARY outcome

Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	4.11 Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	—

SECONDARY outcome

Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.

Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=5 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Interval 17.02 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	NA Months Interval 7.79 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Interval 30.62 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.

SECONDARY outcome

Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	6.87 Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	—

SECONDARY outcome

Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.

Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=5 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Interval 17.02 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	NA Months Interval 3.42 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Interval 5.88 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	35.45 Months Interval 28.32 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.

SECONDARY outcome

Timeframe: Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	6.87 Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	6.70 Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	—

SECONDARY outcome

Timeframe: 6 months

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.

Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=5 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population	100.70 Percentage Standard Deviation 0.99	99.97 Percentage Standard Deviation 0.55	96.04 Percentage Standard Deviation 4.81	—	99.35 Percentage Standard Deviation 3.19	99.95 Percentage Standard Deviation 0.75	96.71 Percentage Standard Deviation 6.99	98.92 Percentage Standard Deviation 3.74

SECONDARY outcome

Timeframe: 6 months

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.

Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population	100.00 Percentage Standard Deviation NA Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	100.94 Percentage Standard Deviation NA Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	132.22 Percentage Standard Deviation NA Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	99.72 Percentage Standard Deviation 0.06	100.17 Percentage Standard Deviation 0.14	—	—

SECONDARY outcome

Timeframe: Screening up to death due to any cause (up to approximately 6 years)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.

The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=5 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=4 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 Participants Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Survival for DLBCL Population	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	NA Months Interval 7.79 to Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.

SECONDARY outcome

Timeframe: Screening up to death due to any cause (up to approximately 6 years)

Population: The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.

Outcome measures

Outcome measures
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=2 Participants Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Overall Survival for Non-DLBCL Population	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	15.24 Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	NA Months Median, Lower and Upper Limit could not be estimated because very few participants had the event of interest.	—	—

Adverse Events

Polatuzumab Vedotin (1.0mg) + R-CHP

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Polatuzumab Vedotin (1.4mg) + R-CHP

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Polatuzumab Vedotin (1.8mg) + R-CHP

Serious events: 4 serious events

Other events: 6 other events

Deaths: 1 deaths

Polatuzumab Vedotin (2.4mg) + R-CHP

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Polatuzumab Vedotin (1.4mg) + G-CHP

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Polatuzumab Vedotin (1.8mg) + G-CHP

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP

Serious events: 15 serious events

Other events: 40 other events

Deaths: 4 deaths

Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP

Serious events: 6 serious events

Other events: 17 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 participants at risk Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 participants at risk Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	23.5% 4/17 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders DIARRHOEA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders VOMITING	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders ASTHENIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations LUNG INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations ORAL FUNGAL INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations PNEUMONIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations SEPSIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations SEPTIC SHOCK	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Injury, poisoning and procedural complications PELVIC FRACTURE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations INFLUENZA A VIRUS TEST POSITIVE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders MALNUTRITION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders SYNCOPE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders ANXIETY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders CHYLOTHORAX	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.

Other adverse events

Other adverse events
Measure	Polatuzumab Vedotin (1.0mg) + R-CHP n=3 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.4mg) + R-CHP n=3 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (1.8mg) + R-CHP n=6 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP.	Polatuzumab Vedotin (2.4mg) + R-CHP n=1 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. The participant in this group was incorrectly dosed on 2.4mg Pola R-CHP group and should have been assigned to the 1.8mg Pola R-CHP group.	Polatuzumab Vedotin (1.4mg) + G-CHP n=6 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Polatuzumab Vedotin (1.8mg) + G-CHP n=6 participants at risk Dose Escalation: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP.	Expansion: Polatuzumab Vedotin (1.8mg) + R-CHP n=40 participants at risk Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with R-CHP. Participants treated with MTD determined from dose escalation cohorts.	Expansion: Polatuzumab Vedotin (1.8mg) + G-CHP n=17 participants at risk Dose Expansion: Participants will receive a total of six to eight 21-day cycles of polatuzumab vedotin in combination with G-CHP. Participants treated with MTD determined from dose escalation cohorts.
Infections and infestations FOLLICULITIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations FUNGAL INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations NASOPHARYNGITIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations BACTERAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations BRONCHITIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.5% 7/40 • Number of events 10 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations CANDIDA INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations CONJUNCTIVITIS VIRAL	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations CYSTITIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	50.0% 3/6 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	35.0% 14/40 • Number of events 24 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 7 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	15.0% 6/40 • Number of events 9 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.5% 7/40 • Number of events 16 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Blood and lymphatic system disorders NEUTROPENIA	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	66.7% 4/6 • Number of events 8 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	50.0% 3/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	83.3% 5/6 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	32.5% 13/40 • Number of events 22 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	35.3% 6/17 • Number of events 9 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Blood and lymphatic system disorders THROMBOCYTOPENIA	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	15.0% 6/40 • Number of events 16 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	35.3% 6/17 • Number of events 6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Cardiac disorders PALPITATIONS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Cardiac disorders TACHYCARDIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Ear and labyrinth disorders CERUMEN IMPACTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Ear and labyrinth disorders EAR DISCOMFORT	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Ear and labyrinth disorders EAR PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Ear and labyrinth disorders EXCESSIVE CERUMEN PRODUCTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Ear and labyrinth disorders HYPOACUSIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Ear and labyrinth disorders MIDDLE EAR EFFUSION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Eye disorders AMBLYOPIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Eye disorders CATARACT	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Eye disorders CONJUNCTIVAL HYPERAEMIA	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Eye disorders CONJUNCTIVAL IRRITATION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Eye disorders DIPLOPIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Eye disorders EYE IRRITATION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Eye disorders LACRIMATION INCREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders ABDOMINAL PAIN	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders COLITIS MICROSCOPIC	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders CONSTIPATION	33.3% 1/3 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	27.5% 11/40 • Number of events 14 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	29.4% 5/17 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders DIARRHOEA	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	83.3% 5/6 • Number of events 7 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	42.5% 17/40 • Number of events 25 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	64.7% 11/17 • Number of events 14 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders DRY MOUTH	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders ERUCTATION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders FLATULENCE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders GASTROINTESTINAL MOTILITY DISORDER	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders HYPERCHLORHYDRIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders NAUSEA	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 3/3 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	66.7% 4/6 • Number of events 7 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	50.0% 3/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	50.0% 3/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	40.0% 16/40 • Number of events 26 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	58.8% 10/17 • Number of events 12 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders ORAL PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders STOMATITIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Gastrointestinal disorders VOMITING	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	15.0% 6/40 • Number of events 8 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders ASTHENIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	22.5% 9/40 • Number of events 12 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders CATHETER SITE PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders CHEST DISCOMFORT	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders CHEST PAIN	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders CHILLS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders DEVICE RELATED THROMBOSIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders FACE OEDEMA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders FATIGUE	66.7% 2/3 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 3/3 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	50.0% 3/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	66.7% 4/6 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	40.0% 16/40 • Number of events 29 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	64.7% 11/17 • Number of events 16 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders FEELING HOT	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders GAIT DISTURBANCE	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders ILL-DEFINED DISORDER	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders MUCOSAL INFLAMMATION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders OEDEMA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders OEDEMA PERIPHERAL	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders PERIPHERAL SWELLING	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
General disorders PYREXIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	22.5% 9/40 • Number of events 11 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	23.5% 4/17 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Hepatobiliary disorders HEPATIC STEATOSIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Immune system disorders SEASONAL ALLERGY	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations OPHTHALMIC HERPES ZOSTER	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations ORAL CANDIDIASIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations OTITIS MEDIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations PNEUMONIA	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations RASH PUSTULAR	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations SINUSITIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations SUBCUTANEOUS ABSCESS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Infections and infestations VASCULAR DEVICE INFECTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Injury, poisoning and procedural complications MEDICATION ERROR	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Injury, poisoning and procedural complications POST LUMBAR PUNCTURE SYNDROME	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Injury, poisoning and procedural complications PROCEDURAL HEADACHE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations BLOOD CREATININE INCREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations BLOOD LACTIC ACID INCREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations BLOOD PHOSPHORUS DECREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations BLOOD POTASSIUM DECREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations EJECTION FRACTION DECREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations PLATELET COUNT DECREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations STAPHYLOCOCCUS TEST POSITIVE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations STREPTOCOCCUS TEST POSITIVE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations TRANSAMINASES INCREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations TROPONIN I INCREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations TROPONIN INCREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations WEIGHT DECREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	50.0% 3/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	15.0% 6/40 • Number of events 6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	29.4% 5/17 • Number of events 6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Investigations WHITE BLOOD CELL COUNT INCREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	12.5% 5/40 • Number of events 7 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	12.5% 5/40 • Number of events 7 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPERNATRAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPERURICAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	23.5% 4/17 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Metabolism and nutrition disorders MALNUTRITION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	23.5% 4/17 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders MUSCLE TIGHTNESS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Musculoskeletal and connective tissue disorders SYNOVIAL CYST	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders BALANCE DISORDER	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders DIZZINESS	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	66.7% 2/3 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders DYSGEUSIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders DYSTONIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders ENCEPHALOPATHY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders HEADACHE	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	66.7% 2/3 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders HYPOAESTHESIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders HYPOGEUSIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders MEMORY IMPAIRMENT	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders NEURALGIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders NEUROPATHY PERIPHERAL	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	12.5% 5/40 • Number of events 7 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders PARAESTHESIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders PERIPHERAL SENSORIMOTOR NEUROPATHY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	15.0% 6/40 • Number of events 6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders SCIATICA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders SOMNOLENCE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders SYNCOPE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Nervous system disorders TREMOR	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders AFFECT LABILITY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders ANXIETY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders DEPRESSION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders INSOMNIA	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	66.7% 2/3 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	12.5% 5/40 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.6% 3/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders IRRITABILITY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders MOOD ALTERED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders NIGHTMARE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Psychiatric disorders RESTLESSNESS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders DYSURIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders HAEMATURIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders POLLAKIURIA	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders RENAL COLIC	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders RENAL FAILURE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders RENAL IMPAIRMENT	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders URINARY RETENTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Renal and urinary disorders URINE FLOW DECREASED	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Reproductive system and breast disorders PELVIC PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Reproductive system and breast disorders TESTICULAR OEDEMA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Reproductive system and breast disorders VAGINAL DISCHARGE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	50.0% 3/6 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	7.5% 3/40 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders LOWER RESPIRATORY TRACT CONGESTION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders PARANASAL SINUS HYPERSECRETION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	50.0% 3/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders TACHYPNOEA	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders THROAT TIGHTNESS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Respiratory, thoracic and mediastinal disorders UPPER-AIRWAY COUGH SYNDROME	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders ALOPECIA	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	83.3% 5/6 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	66.7% 4/6 • Number of events 4 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	10.0% 4/40 • Number of events 7 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	23.5% 4/17 • Number of events 5 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders ERYTHEMA	33.3% 1/3 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	11.8% 2/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders NAIL RIDGING	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders PAIN OF SKIN	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders PAPULE	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders PRURITUS	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders RASH	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	50.0% 3/6 • Number of events 3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Vascular disorders DEEP VEIN THROMBOSIS	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Vascular disorders EMBOLISM	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Vascular disorders FLUSHING	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	100.0% 1/1 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	2.5% 1/40 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Vascular disorders HOT FLUSH	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Vascular disorders HYPERTENSION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	16.7% 1/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	17.5% 7/40 • Number of events 16 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Vascular disorders HYPOTENSION	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 2/6 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.0% 2/40 • Number of events 2 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	5.9% 1/17 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.
Vascular disorders PHLEBITIS	0.00% 0/3 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	33.3% 1/3 • Number of events 1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/1 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/6 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/40 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.	0.00% 0/17 • 5 years The safety population was defined as all participants who received at least one dose of study medication. AEs that were entered into the data base at the time of the data base lock were included in the AE analysis.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER