Trial Outcomes & Findings for A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (NCT NCT02600897)

Last Updated: 2023-12-26

Results Overview

A DLT was defined as any one of the following toxicities occurring during the first cycle of treatment and assessed by the investigator as related to study treatment: Any adverse event of any grade that lead to a delay of \> 14 days in the start of the next treatment cycle, Grade 3 or 4 non-hematologic adverse events with few exceptions; increase in hepatic transaminase \> 3 x baseline and an increase in direct bilirubin \> 2 x upper limits of normal (ULN), without any findings of cholestasis or jaundice, or signs of hepatic dysfunction, and in the absence of other contributory factors; hematologic adverse events that met a few protocol specified criteria. DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Percentages have been rounded off to the first decimal point.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

114 participants

Primary outcome timeframe

Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle = 28 days) in dose-escalation phase

Results posted on

2023-12-26

Participant Flow

A total of 114 participants with relapsed or refractory (R/R) follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) were enrolled in this study at 28 investigative sites in Spain, United Kingdom, and United States from 24 March 2016 to 15 December 2021. The study consisted of two phases: dose-escalation and dose-expansion phase. All eligible participants in both phases received induction and post-induction therapy.

Participants were enrolled in Phase Ib and Phase II study to receive polatuzumab vedotin (pola) in combination with lenalidomide (L) \& fixed doses of rituximab (R)/obinutuzumab(G). Of the 114 enrolled participants, 113 participants received at least one dose of the study drug and their intended treatment. One participant withdrew consent prior to receiving any study treatment.

Participant milestones

Participant milestones
Measure	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 10 milligrams (mg) capsules orally once daily (QD) on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as intravenous (IV) infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 milligrams per kilogram (mg/kg), IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.8 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 15 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Overall Study STARTED	40	40	3	4	3	6	3	5	10
Overall Study Intent-to-Treat Population	40	40	3	4	3	6	3	5	10
Overall Study Safety-evaluable Population	40	39	3	4	3	6	3	5	10
Overall Study Immunogenicity-evaluable Population	39	38	3	4	3	6	3	5	10
Overall Study Pharmacokinetic-evaluable Population	40	39	3	4	3	6	3	5	10
Overall Study COMPLETED	28	17	1	2	2	4	0	3	0
Overall Study NOT COMPLETED	12	23	2	2	1	2	3	2	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 10 milligrams (mg) capsules orally once daily (QD) on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as intravenous (IV) infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 milligrams per kilogram (mg/kg), IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.8 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 15 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Overall Study Lost to Follow-up	1	0	1	0	0	0	0	0	0
Overall Study Death	7	20	1	2	1	2	3	2	10
Overall Study Withdrawal by Subject	4	2	0	0	0	0	0	0	0
Overall Study Reason Not Specified	0	1	0	0	0	0	0	0	0

Baseline Characteristics

A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=40 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Total n=114 Participants Total of all reporting groups	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL n=4 Participants Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.8 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 15 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=5 Participants Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
Age, Continuous	68.4 years STANDARD_DEVIATION 12.8 • n=42 Participants	64.0 years STANDARD_DEVIATION 12.2 • n=42 Participants	61.3 years STANDARD_DEVIATION 6.1 • n=5 Participants	72.5 years STANDARD_DEVIATION 8.1 • n=7 Participants	56.0 years STANDARD_DEVIATION 3.5 • n=5 Participants	58.3 years STANDARD_DEVIATION 12.0 • n=4 Participants	59.7 years STANDARD_DEVIATION 6.5 • n=21 Participants	62.0 years STANDARD_DEVIATION 14.9 • n=8 Participants	61.4 years STANDARD_DEVIATION 14.2 • n=8 Participants	61.6 years STANDARD_DEVIATION 11.2 • n=24 Participants
Sex: Female, Male Female	14 Participants n=42 Participants	42 Participants n=42 Participants	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants	12 Participants n=24 Participants
Sex: Female, Male Male	26 Participants n=42 Participants	72 Participants n=42 Participants	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	6 Participants n=8 Participants	28 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) White	38 Participants n=42 Participants	108 Participants n=42 Participants	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	10 Participants n=8 Participants	36 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=42 Participants	4 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	4 Participants n=42 Participants	12 Participants n=42 Participants	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	1 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	34 Participants n=42 Participants	97 Participants n=42 Participants	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	7 Participants n=8 Participants	34 Participants n=24 Participants
Race/Ethnicity, Customized Ethnicity · Not Stated	1 Participants n=42 Participants	4 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle = 28 days) in dose-escalation phase

Population: The safety-evaluable population included all participants who received at least one dose of any component of the combination.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=6 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=5 Participants Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With Dose-Limiting Toxicities (DLTs)	0.0 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	—

PRIMARY outcome

Timeframe: From study start up to end of study (Up to a maximum of 69 months)

Population: The safety-evaluable population included all participants who received at least one dose of any component of the combination.

An AE 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 AE 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. Percentages have been rounded off to the first decimal point.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=6 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=5 Participants Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With Adverse Events (AEs)	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	97.4 percentage of participants

PRIMARY outcome

Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

Population: Efficacy-evaluable population=dose expansion participants who received atleast 1 dose of any component of the combination. As pre-specified in the protocol, data was collected and analysed only for participants in expansion phase arms \& those participants in dose-escalation arms who received study drugs at RP2D (i.e. arms: 1.4 mg Pola + 20 mg L+1000G for FL; 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL), for this OM.

CR at EOI was assessed by IRC according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS) where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immunohistochemistry (IHC) negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With Complete Response (CR) at End of Induction (EOI), Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography (PET) and Computed Tomography (CT) Scans	38.5 percentage of participants Interval 25.41 to 52.89	66.7 percentage of participants Interval 27.13 to 93.72	0.0 percentage of participants Interval 0.0 to 25.89	60.0 percentage of participants Interval 45.78 to 73.06	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

CR at EOI was assessed by Investigator according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of PET-CT Scans	33.3 percentage of participants Interval 20.97 to 47.69	66.7 percentage of participants Interval 27.13 to 93.72	0.0 percentage of participants Interval 0.0 to 25.89	60.0 percentage of participants Interval 45.78 to 73.06	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

CR at EOI was determined by IRC according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in longest transverse diameter (LDi) and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=32 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=8 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=35 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With CR at EOI, Determined by the IRC on the Basis of CT Scans Alone	12.5 percentage of participants Interval 4.38 to 26.36	16.7 percentage of participants Interval 0.85 to 58.18	0.0 percentage of participants Interval 0.0 to 31.23	31.4 percentage of participants Interval 18.73 to 46.61	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

CR at EOI was determined by Investigator according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=32 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=9 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=37 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With CR at EOI, Determined by Investigator on the Basis of CT Scans Alone	28.1 percentage of participants Interval 15.53 to 43.94	16.7 percentage of participants Interval 0.85 to 58.18	0.0 percentage of participants Interval 0.0 to 28.31	29.7 percentage of participants Interval 17.65 to 44.38	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (cycle=28 days) (up to approximately 28 weeks)

OR was defined as percentage of participants with CR or PR as assessed by the IRC according to MLRC. Per MLRC CR based on PET-CT is complete MR in lymph nodes \& ELS with score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake\> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions;no new lesions \& no evidence of FDG-avid disease in bone marrow.Bone marrow is normal by morphology; if indeterminate, IHC negative. Partial response (PR) based on PET-CT was defined as partial MR in lymph nodes \& ELS with score of 4 or 5 with reduced uptake compared with baseline \& residual masses of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). Percentages have been rounded off up to the second decimal point.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With Objective Response (OR) at EOI, Determined by the IRC on the Basis of PET-CT Scans	46.20 percentage of participants Interval 32.35 to 60.42	100.0 percentage of participants Interval 60.7 to 100.0	10.0 percentage of participants Interval 0.51 to 39.42	72.50 percentage of participants Interval 58.61 to 83.75	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

OR was defined percentage of participants with CR or PR assessed by the investigator according to MLRC. Per MLRC CR based on PET-CT is complete MR in lymph nodes \& ELS with score of 1, 2, 3 with or without residual mass on 5PS, where 1=no uptake above background 2=uptake ≤ mediastinum 3=uptake\> mediastinum but ≤ liver 4=uptake moderately \> liver 5=uptake markedly higher than liver and/or new lesions;no new lesions \& no evidence of FDG-avid disease in bone marrow.Bone marrow is normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes \& ELS with score of 4 or 5 with reduced uptake compared with baseline \& residual masses of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline(diffuse uptake compatible with reactive changes from chemotherapy allowed). Percentages are rounded off.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With Objective Response at EOI, Determined by Investigator on the Basis of PET-CT Scans	46.20 percentage of participants Interval 32.35 to 60.42	100.0 percentage of participants Interval 60.7 to 100.0	10.0 percentage of participants Interval 0.51 to 39.42	80.0 percentage of participants Interval 66.8 to 89.64	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

OR was defined as the percentage of participants with CR or PR, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 28 days). Percentages have been rounded off to the first decimal point.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=32 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=8 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=35 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With Objective Response at EOI, Determined by the IRC on the Basis of CT Scans Alone	53.1 percentage of participants Interval 37.34 to 68.46	100.0 percentage of participants Interval 60.7 to 100.0	12.5 percentage of participants Interval 0.64 to 47.07	91.4 percentage of participants Interval 79.31 to 97.62	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

OR was defined as the percentage of participants with CR or PR, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in the sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. Analysis was done 6-8 weeks after Cycle 6, Day 1 (cycle=28 days). Percentages have been rounded off to the first decimal point.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=32 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=9 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=37 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of CT Scans Alone	59.4 percentage of participants Interval 43.35 to 74.03	100.0 percentage of participants Interval 60.7 to 100.0	11.1 percentage of participants Interval 0.57 to 42.91	89.2 percentage of participants Interval 76.95 to 96.22	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to every 6 months until disease progression, unacceptable toxicity or study completion (up to approximately 69 months)

BOR=CR/PR per CT per MLRC. Per MLRC, CR based on CT was defined as a complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. Percentages have been rounded off to the first decimal point.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Percentage of Participants With Best Response of CR or PR, Determined by the Investigator on the Basis of CT Scans Alone	79.5 percentage of participants Interval 66.02 to 89.36	100.0 percentage of participants Interval 60.7 to 100.0	50.0 percentage of participants Interval 22.24 to 77.76	90.0 percentage of participants Interval 78.56 to 96.51	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, 4 & 6: predose & 30 mins postdose; EOI: predose; Day 1 of Maintenance Months 1,7, 13, 19;Day 120 post last dose; one year post last dose; study drug discontinuation; unscheduled visit: predose (up to approximately 69 months)

Population: The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable postdose PK sample. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

1 cycle = 28 days

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=6 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=38 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Observed Serum Obinutuzumab Concentration Induction Cycle 1 Day 1 / Predose	NA micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were below lower limit of quantification (BLLQ).	NA micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	—	—	—	—
Observed Serum Obinutuzumab Concentration Induction Cycle 1 Day 1 / 30 mins	333 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 70.0	394 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 22.1	358 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 20.5	351 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 15.2	182 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 206.7	—	—	—	—
Observed Serum Obinutuzumab Concentration Induction Cycle 2 Day 1 / Predose	481 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 23.1	451 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 23.5	372 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 37.0	386 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 4.6	312 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 40.8	—	—	—	—
Observed Serum Obinutuzumab Concentration Induction Cycle 2 Day 1 / 30 mins	667 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 77.5	830 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 38.3	749 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 17.2	695 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 14.3	588 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 41.4	—	—	—	—
Observed Serum Obinutuzumab Concentration Induction Cycle 4 Day 1 / Predose	405 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 24.9	354 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 15.0	321 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 43.6	344 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 13.4	270 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 41.8	—	—	—	—
Observed Serum Obinutuzumab Concentration Induction Cycle 4 Day 1 / 30 mins	742 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 27.8	103 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	644 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 42.8	653 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 20.6	547 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 37.1	—	—	—	—
Observed Serum Obinutuzumab Concentration Induction Cycle 6 Day 1 / Predose	384 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 52.2	255 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 36.6	504 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	327 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 5.8	255 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 49.0	—	—	—	—
Observed Serum Obinutuzumab Concentration Induction Cycle 6 Day 1 / 30 mins	751 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 35.3	730 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 15.5	804 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	1.18 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Values were less than reportable (LTR) for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not calculated.	543 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 36.2	—	—	—	—
Observed Serum Obinutuzumab Concentration EOI / Predose	—	108 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 32.6	—	—	—	—	—	—	—
Observed Serum Obinutuzumab Concentration Maintenance Month 1 / Predose	230 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 87.4	231 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 19.1	381 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	176 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 60.1	—	—	—	—
Observed Serum Obinutuzumab Concentration Maintenance Month 7 / Predose	125 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 143.7	128 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	212 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	229 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	135 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 64.3	—	—	—	—
Observed Serum Obinutuzumab Concentration Maintenance Month 13 / Predose	134 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 105.3	—	142 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	269 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	150 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 70.7	—	—	—	—
Observed Serum Obinutuzumab Concentration Maintenance Month 19 / Predose	154 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 144.1	—	354 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	204 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	165 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 59.5	—	—	—	—
Observed Serum Obinutuzumab Concentration Study Drug Discontinuation	17.3 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	46.4 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	87.5 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 588.7	—	—	—	—
Observed Serum Obinutuzumab Concentration Day 120 Post Last Dose	—	29.1 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	44.5 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 806.5	—	—	—	—
Observed Serum Obinutuzumab Concentration 1 Year Post Last Dose	—	—	—	0.377 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.340 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 955.9	—	—	—	—
Observed Serum Obinutuzumab Concentration Unscheduled / Predose	—	—	—	—	561 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, 4, 6: predose and 30 mins post-dose (1 cycle = 28 days) (up to approximately 69 months)

Population: The PK-evaluable population included all participants who received at least one dose of any component of the combination and who provided at least one suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=37 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=5 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=10 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Observed Serum Rituximab Concentration Induction Cycle 1 Day 1 / Predose	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	—	—	—	—	—
Observed Serum Rituximab Concentration Induction Cycle 1 Day 1 / 30 mins	174 μg/mL Geometric Coefficient of Variation 45.4	151 μg/mL Geometric Coefficient of Variation 42.9	203 μg/mL Geometric Coefficient of Variation 28.1	175 μg/mL Geometric Coefficient of Variation 18.7	—	—	—	—	—
Observed Serum Rituximab Concentration Induction Cycle 2 Day 1 / Predose	26.4 μg/mL Geometric Coefficient of Variation 73.4	25.6 μg/mL Geometric Coefficient of Variation 78.0	33.3 μg/mL Geometric Coefficient of Variation 43.7	31.7 μg/mL Geometric Coefficient of Variation 26.2	—	—	—	—	—
Observed Serum Rituximab Concentration Induction Cycle 2 Day 1 / 30 mins	194 μg/mL Geometric Coefficient of Variation 36.4	133 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	172 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	222 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—	—
Observed Serum Rituximab Concentration Induction Cycle 4 Day 1 / Predose	58.3 μg/mL Geometric Coefficient of Variation 44.4	20.4 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	74.6 μg/mL Geometric Coefficient of Variation 33.8	53.1 μg/mL Geometric Coefficient of Variation 43.7	—	—	—	—	—
Observed Serum Rituximab Concentration Induction Cycle 4 Day 1 / 30 mins	228 μg/mL Geometric Coefficient of Variation 36.6	159 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	224 μg/mL Geometric Coefficient of Variation 5.7	220 μg/mL Geometric Coefficient of Variation 16.2	—	—	—	—	—
Observed Serum Rituximab Concentration Induction Cycle 6 Day 1 / Predose	68.9 μg/mL Geometric Coefficient of Variation 60.6	15.3 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	79.5 μg/mL Geometric Coefficient of Variation 42.3	74.7 μg/mL Geometric Coefficient of Variation 22.1	—	—	—	—	—
Observed Serum Rituximab Concentration Induction Cycle 6 Day 1 / 30 mins	256 μg/mL Geometric Coefficient of Variation 26.4	135 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	250 μg/mL Geometric Coefficient of Variation 7.6	233 μg/mL Geometric Coefficient of Variation 1.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, 4: predose (1 cycle = 28 days), Day 120 post last dose; one year post last dose; study drug discontinuation; unscheduled visit: predose (up to approximately 69 months)

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=6 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=7 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=37 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=37 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody Induction Cycle 1 Day 1 / Predose	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA μg/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.
Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody Induction Cycle 2 Day 1 / Predose	0.622 μg/mL Geometric Coefficient of Variation 152.8	1.47 μg/mL Geometric Coefficient of Variation 16.2	2.01 μg/mL Geometric Coefficient of Variation 51.1	0.200 μg/mL Geometric Coefficient of Variation 958.3	1.57 μg/mL Geometric Coefficient of Variation 62.9	1.61 μg/mL Geometric Coefficient of Variation 59.8	1.47 μg/mL Geometric Coefficient of Variation 26.2	0.339 μg/mL Geometric Coefficient of Variation 391.8	1.35 μg/mL Geometric Coefficient of Variation 122.0
Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody Induction Cycle 4 Day 1 / Predose	2.12 μg/mL Geometric Coefficient of Variation 69.0	1.83 μg/mL Geometric Coefficient of Variation 51.7	4.45 μg/mL Geometric Coefficient of Variation 20.5	2.57 μg/mL Geometric Coefficient of Variation 30.5	0.900 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	2.96 μg/mL Geometric Coefficient of Variation 44.4	3.10 μg/mL Geometric Coefficient of Variation 43.6	2.31 μg/mL Geometric Coefficient of Variation 48.5	3.42 μg/mL Geometric Coefficient of Variation 46.1
Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody Study Drug Discontinuation	0.0903 μg/mL Geometric Coefficient of Variation NA Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not calculated.	0.106 μg/mL Geometric Coefficient of Variation 209.1	0.170 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	1.50 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	6.16 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	3.25 μg/mL Geometric Coefficient of Variation 49.7	0.175 μg/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.455 μg/mL Geometric Coefficient of Variation 448.4
Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody Day 120 Post Last Dose	—	0.0661 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	0.208 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.107 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0365 μg/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0666 μg/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.
Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody 1 Year Post Last Dose	—	0.0250 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	0.0250 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	0.0357 μg/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0250 μg/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.
Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody Unscheduled / Predose	—	—	—	—	—	—	—	—	2.59 μg/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, 4: predose and 30 mins post-dose; Days 8 and 15 of Cycle 1; Day 1 of Cycle 6: predose, study drug discontinuation; unscheduled visit: predose (1 cycle = 28 days) (up to approximately 69 months)

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=6 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=5 Participants Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Induction Cycle 1 Day 1 / Predose	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Induction Cycle 1 Day 1 / 30 mins	432 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.9	580 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.6	660 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 24.7	476 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 16.0	568 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.7	106 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 60902.6	513 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 73.5	333 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 267.2	522 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 323.0
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Induction Cycle 1 Day 8	27.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 69.2	50.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 7.3	80.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 17.6	11.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 232.2	58.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 44.4	52.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 36.3	43.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 96.4	11.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 799.0	56.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 90.2
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Induction Cycle 1 Day 15	6.73 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 118.8	17.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 5.5	24.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 13.8	2.50 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 483.1	22.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 31.2	18.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 48.7	18.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 30.5	5.95 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 366.1	16.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 118.6
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Induction Cycle 2 Day 1 / Predose	2.50 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 119.8	4.96 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 21.3	6.55 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 58.7	0.961 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 477.5	7.44 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 40.2	5.58 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 77.2	6.12 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 18.1	1.88 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 490.2	5.32 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 103.6
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Induction Cycle 2 Day 1 / 30 mins	295 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 174.6	555 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 15.8	623 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 18.4	508 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 22.7	537 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 40.3	568 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 14.1	716 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 16.5	481 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 54.3	451 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 391.7
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Induction Cycle 4 Day 1 / Predose	7.68 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 60.8	5.34 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 73.9	11.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	8.47 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 19.5	4.19 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	8.25 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 59.4	11.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 74.2	8.99 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 36.7	11.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 45.2
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Induction Cycle 4 Day 1 / 30 mins	531 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 17.6	32.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 101980.7	416 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 87.7	519 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 9.3	371 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	507 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 42.8	737 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 20.8	492 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 22.3	645 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 107.2
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Induction Cycle 6 Day 1 / Predose	9.70 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 53.0	7.70 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 26.0	19.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	9.37 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 42.6	3.06 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	11.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.6	15.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 45.4	9.82 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 40.4	11.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 66.0
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Study Drug Discontinuation	0.180 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.180 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not calculated.	0.635 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—	1.71 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 378.4	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) Unscheduled / Predose	—	—	—	—	—	—	—	23.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 62.5	9.78 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, 4: predose and 30 mins post-dose; Days 8 and 15 of Cycle 1 and Day 1 of Cycle 6: predose, study drug discontinuation; unscheduled visit: predose (1 cycle = 28 days) (up to approximately 69 months)

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=6 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=5 Participants Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Induction Cycle 1 Day 1 / Predose	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Induction Cycle 1 Day 1 / 30 mins	0.233 ng/mL Geometric Coefficient of Variation 74.0	0.228 ng/mL Geometric Coefficient of Variation 7.8	0.160 ng/mL Geometric Coefficient of Variation 69.9	0.420 ng/mL Geometric Coefficient of Variation 100.6	0.156 ng/mL Geometric Coefficient of Variation 62.1	0.167 ng/mL Geometric Coefficient of Variation 214.8	0.298 ng/mL Geometric Coefficient of Variation 198.7	0.347 ng/mL Geometric Coefficient of Variation 327.5	0.297 ng/mL Geometric Coefficient of Variation 111.1
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Induction Cycle 1 Day 8	1.64 ng/mL Geometric Coefficient of Variation 135.5	1.15 ng/mL Geometric Coefficient of Variation 34.9	2.05 ng/mL Geometric Coefficient of Variation 49.7	2.40 ng/mL Geometric Coefficient of Variation 102.0	1.89 ng/mL Geometric Coefficient of Variation 76.1	1.36 ng/mL Geometric Coefficient of Variation 29.6	3.65 ng/mL Geometric Coefficient of Variation 75.3	1.12 ng/mL Geometric Coefficient of Variation 227.0	2.56 ng/mL Geometric Coefficient of Variation 144.8
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Induction Cycle 1 Day 15	0.435 ng/mL Geometric Coefficient of Variation 129.5	0.457 ng/mL Geometric Coefficient of Variation 56.3	0.459 ng/mL Geometric Coefficient of Variation 54.5	0.387 ng/mL Geometric Coefficient of Variation 6.0	0.485 ng/mL Geometric Coefficient of Variation 204.0	0.456 ng/mL Geometric Coefficient of Variation 39.8	0.683 ng/mL Geometric Coefficient of Variation 63.3	0.294 ng/mL Geometric Coefficient of Variation 170.9	0.843 ng/mL Geometric Coefficient of Variation 125.2
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Induction Cycle 2 Day 1 / Predose	0.0334 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0280 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0315 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0244 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0501 ng/mL Geometric Coefficient of Variation 149.0	0.0310 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0527 ng/mL Geometric Coefficient of Variation 102.8	0.0268 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0713 ng/mL Geometric Coefficient of Variation 125.0
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Induction Cycle 2 Day 1 / 30 mins	0.136 ng/mL Geometric Coefficient of Variation 339.9	0.151 ng/mL Geometric Coefficient of Variation 68.6	0.138 ng/mL Geometric Coefficient of Variation 133.0	0.151 ng/mL Geometric Coefficient of Variation 49.8	0.186 ng/mL Geometric Coefficient of Variation 51.2	0.123 ng/mL Geometric Coefficient of Variation 53.8	0.157 ng/mL Geometric Coefficient of Variation 72.5	0.102 ng/mL Geometric Coefficient of Variation 101.2	0.210 ng/mL Geometric Coefficient of Variation 77.3
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Induction Cycle 4 Day 1 / Predose	0.0283 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0431 ng/mL Geometric Coefficient of Variation NA Values were LTR for 2 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not calculated.	0.117 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0672 ng/mL Geometric Coefficient of Variation 56.9	0.0180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0344 ng/mL Geometric Coefficient of Variation 61.0	0.0729 ng/mL Geometric Coefficient of Variation 11.4	0.0366 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0776 ng/mL Geometric Coefficient of Variation 101.5
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Induction Cycle 4 Day 1 / 30 mins	0.0752 ng/mL Geometric Coefficient of Variation 113.2	0.0817 ng/mL Geometric Coefficient of Variation NA Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not calculated.	0.156 ng/mL Geometric Coefficient of Variation 18.7	0.104 ng/mL Geometric Coefficient of Variation 7.1	0.0180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.133 ng/mL Geometric Coefficient of Variation 50.9	0.208 ng/mL Geometric Coefficient of Variation 44.9	0.102 ng/mL Geometric Coefficient of Variation 57.7	0.213 ng/mL Geometric Coefficient of Variation 51.3
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Induction Cycle 6 Day 1 / Predose	0.0267 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0367 ng/mL Geometric Coefficient of Variation 68.3	0.0929 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0821 ng/mL Geometric Coefficient of Variation 93.8	0.0180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0517 ng/mL Geometric Coefficient of Variation 118.9	0.0405 ng/mL Geometric Coefficient of Variation NA Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not calculated.	0.0342 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	0.0852 ng/mL Geometric Coefficient of Variation 62.6
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Study Drug Discontinuation	0.0180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0180 ng/mL Geometric Coefficient of Variation NA Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not calculated.	0.0180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—	0.0180 ng/mL Geometric Coefficient of Variation NA Since more than one-third values were less than reportable, the geometric coefficient of variation was not calculated.	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Unscheduled / Predose	—	—	—	—	—	—	—	0.180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.

SECONDARY outcome

Timeframe: Day 1 Cycle 1: predose and 2 hours (hr) post-dose; Day 15 Cycle 1: predose, 0.5hr, 1hr, 2hr, 4hr, 8hr post-dose; Day 1 Cycle 6: 2hr post-dose; unscheduled visits: 2hr post-dose (1 cycle = 28 days) (up to approximately 69 months)

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=6 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=37 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=37 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Observed Plasma Lenalidomide Concentration Induction Cycle 1 Day 1 / Predose	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.
Observed Plasma Lenalidomide Concentration Induction Cycle 1 Day 1 / 2h	305 ng/mL Geometric Coefficient of Variation 37.1	118 ng/mL Geometric Coefficient of Variation 44.0	144 ng/mL Geometric Coefficient of Variation 30.3	201 ng/mL Geometric Coefficient of Variation 54.0	25.2 ng/mL Geometric Coefficient of Variation 239.4	237 ng/mL Geometric Coefficient of Variation 47.4	197 ng/mL Geometric Coefficient of Variation 184.1	306 ng/mL Geometric Coefficient of Variation 43.1	277 ng/mL Geometric Coefficient of Variation 60.0
Observed Plasma Lenalidomide Concentration Induction Cycle 1 Day 15 / Predose	5.20 ng/mL Geometric Coefficient of Variation 275.1	5.97 ng/mL Geometric Coefficient of Variation 628.0	0.729 ng/mL Geometric Coefficient of Variation 540.0	8.74 ng/mL Geometric Coefficient of Variation 277.0	5.43 ng/mL Geometric Coefficient of Variation 9.1	2.64 ng/mL Geometric Coefficient of Variation 68.0	8.33 ng/mL Geometric Coefficient of Variation 112.0	9.99 ng/mL Geometric Coefficient of Variation 260.9	10.4 ng/mL Geometric Coefficient of Variation 196.4
Observed Plasma Lenalidomide Concentration Induction Cycle 1 Day 15 / 30 min	202 ng/mL Geometric Coefficient of Variation 115.6	64.0 ng/mL Geometric Coefficient of Variation 1553.1	1.95 ng/mL Geometric Coefficient of Variation NA Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not calculated.	179 ng/mL Geometric Coefficient of Variation 220.1	12.5 ng/mL Geometric Coefficient of Variation 76.4	41.7 ng/mL Geometric Coefficient of Variation 546.7	73.3 ng/mL Geometric Coefficient of Variation 395.5	124 ng/mL Geometric Coefficient of Variation 300.3	94.5 ng/mL Geometric Coefficient of Variation 204.9
Observed Plasma Lenalidomide Concentration Induction Cycle 1 Day 15 / 1h	272 ng/mL Geometric Coefficient of Variation 48.2	61.4 ng/mL Geometric Coefficient of Variation 1354.8	40.8 ng/mL Geometric Coefficient of Variation 183.1	189 ng/mL Geometric Coefficient of Variation 48.0	69.9 ng/mL Geometric Coefficient of Variation 10.3	224 ng/mL Geometric Coefficient of Variation 76.8	187 ng/mL Geometric Coefficient of Variation 150.5	236 ng/mL Geometric Coefficient of Variation 147.7	245 ng/mL Geometric Coefficient of Variation 106.8
Observed Plasma Lenalidomide Concentration Induction Cycle 1 Day 15 / 2h	200 ng/mL Geometric Coefficient of Variation 45.5	117 ng/mL Geometric Coefficient of Variation 53.2	93.3 ng/mL Geometric Coefficient of Variation 40.5	202 ng/mL Geometric Coefficient of Variation 36.0	118 ng/mL Geometric Coefficient of Variation 22.3	232 ng/mL Geometric Coefficient of Variation 25.5	328 ng/mL Geometric Coefficient of Variation 38.2	305 ng/mL Geometric Coefficient of Variation 53.6	242 ng/mL Geometric Coefficient of Variation 297.2
Observed Plasma Lenalidomide Concentration Induction Cycle 1 Day 15 / 4h	152 ng/mL Geometric Coefficient of Variation 36.9	96.4 ng/mL Geometric Coefficient of Variation 62.0	65.7 ng/mL Geometric Coefficient of Variation 46.3	116 ng/mL Geometric Coefficient of Variation 28.9	79.9 ng/mL Geometric Coefficient of Variation 28.2	134 ng/mL Geometric Coefficient of Variation 23.6	245 ng/mL Geometric Coefficient of Variation 36.3	214 ng/mL Geometric Coefficient of Variation 41.1	205 ng/mL Geometric Coefficient of Variation 45.4
Observed Plasma Lenalidomide Concentration Induction Cycle 1 Day 15 / 8h	49.8 ng/mL Geometric Coefficient of Variation 23.3	35.0 ng/mL Geometric Coefficient of Variation 109.1	29.2 ng/mL Geometric Coefficient of Variation 55.2	56.8 ng/mL Geometric Coefficient of Variation 57.2	44.0 ng/mL Geometric Coefficient of Variation 40.2	57.0 ng/mL Geometric Coefficient of Variation 19.1	105 ng/mL Geometric Coefficient of Variation 50.9	103 ng/mL Geometric Coefficient of Variation 56.3	103 ng/mL Geometric Coefficient of Variation 67.6
Observed Plasma Lenalidomide Concentration Induction Cycle 6 Day 1 / 2h	227 ng/mL Geometric Coefficient of Variation 48.1	124 ng/mL Geometric Coefficient of Variation 21.4	76.1 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	110 ng/mL Geometric Coefficient of Variation 35.1	36.2 ng/mL Geometric Coefficient of Variation NA Values were LTR for 1 participant. Since data was evaluable only for 1 participant geometric co-efficient of variation was not calculated.	258 ng/mL Geometric Coefficient of Variation 10.5	255 ng/mL Geometric Coefficient of Variation 36.5	237 ng/mL Geometric Coefficient of Variation 52.1	153 ng/mL Geometric Coefficient of Variation 515.5
Observed Plasma Lenalidomide Concentration Unscheduled / 2h	—	—	—	—	—	—	—	199 ng/mL Geometric Coefficient of Variation 53.3	—

SECONDARY outcome

Timeframe: Baseline up to approximately 2 years after last dose (up to approximately 69 months)

Population: Immunogenicity population included all safety-evaluable participants with at least one ADA Sample. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

The number of participants with positive results for HAHAs, also called anti-drug antibodies (ADAs) against obinutuzumab at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=6 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=2 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=38 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Number of Participants With Human Anti-human Antibodies (HAHAs) to Obinutuzumab Baseline prevalence of ADAs	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	—	—	—	—
Number of Participants With Human Anti-human Antibodies (HAHAs) to Obinutuzumab Post baseline incidence of ADAs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to approximately 2 years after last dose (up to approximately 69 months)

The number of participants with positive results for HACAs, also called ADAs against rituximab at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=37 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=5 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=10 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Number of Participants With Human Anti-chimeric Antibodies (HACAs) to Rituximab Baseline prevalence of ADAs	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Number of Participants With Human Anti-chimeric Antibodies (HACAs) to Rituximab Post baseline incidence of ADAs	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to approx. 2 years after the last dose of polatuzumab vedotin (up to approximately 30 months)

Population: Immunogenicity population included all safety-evaluable participants with at least one ADA sample. Due to missing baseline or post-baseline results not every participant was evaluable for baseline prevalence or post-baseline incidence of ADAs. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

The number of participants with positive results for ATAs, also called ADAs against polatuzumab vedotin at baseline and at any of the post-baseline assessment time-points were reported. Number of participants positive for Treatment Emergent ADA = the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result.

Outcome measures

Outcome measures
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=6 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=4 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=3 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 Participants Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=5 Participants Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=39 Participants Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=38 Participants Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR and PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.
Number of Participants With Anti-therapeutic Antibodies (ATAs) to Polatuzumab Vedotin Baseline prevalence of ADAs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Anti-therapeutic Antibodies (ATAs) to Polatuzumab Vedotin Post baseline incidence of ADAs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL

Serious events: 19 serious events

Other events: 37 other events

Deaths: 20 deaths

Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL

Serious events: 3 serious events

Other events: 6 other events

Deaths: 2 deaths

Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL

Serious events: 0 serious events

Other events: 5 other events

Deaths: 2 deaths

Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL

Serious events: 4 serious events

Other events: 9 other events

Deaths: 10 deaths

Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL

Serious events: 26 serious events

Other events: 40 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 participants at risk Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL n=3 participants at risk Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL n=4 participants at risk Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.8 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months	Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL n=3 participants at risk Participants with FL received lenalidomide, 15 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 participants at risk Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 participants at risk Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=5 participants at risk Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 participants at risk Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 participants at risk Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Cardiac disorders ACUTE CORONARY SYNDROME	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Cardiac disorders CARDIAC FAILURE	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Cardiac disorders PERICARDITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Eye disorders VISION BLURRED	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders COLITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders DIARRHOEA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders GASTRIC HAEMORRHAGE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders LIP SWELLING	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders PYREXIA	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations BRONCHIOLITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations CELLULITIS	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations COVID-19	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations COVID-19 PNEUMONIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations EPIDIDYMITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations INJECTION SITE INFECTION	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations LUNG ABSCESS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations NEUTROPENIC SEPSIS	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations PNEUMONIA	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations RESPIRATORY TRACT INFECTION	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations SEPSIS	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations SEPTIC SHOCK	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations UROSEPSIS	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications FALL	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations C-REACTIVE PROTEIN INCREASED	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR FLARE	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders BRAIN STEM STROKE	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders ENCEPHALOPATHY	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders ISCHAEMIC STROKE	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders SEIZURE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Renal and urinary disorders ACUTE KIDNEY INJURY	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Renal and urinary disorders RENAL FAILURE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Renal and urinary disorders URINARY RETENTION	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders HYPOXIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders RASH	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders STEVENS-JOHNSON SYNDROME	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.

Other adverse events

Other adverse events
Measure	Expansion Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=39 participants at risk Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL n=3 participants at risk Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL n=4 participants at risk Participants with FL received lenalidomide, 10 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.8 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months	Dose-escalation Phase: 1.4 mg Pola + 15 mg L + 1000 mg G in FL n=3 participants at risk Participants with FL received lenalidomide, 15 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=6 participants at risk Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.	Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 375 mg R in DLBCL n=3 participants at risk Participants with DLBCL received lenalidomide, 10 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 milligrams per square meter (mg/m\^2), as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 15 mg L + 375 mg R in DLBCL n=5 participants at risk Participants with DLBCL received lenalidomide, 15 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Dose-escalation Phase: 1.8 mg Pola + 20 mg L + 375 mg R in DLBCL n=10 participants at risk Participants with DLBCL received lenalidomide, 20 mg, capsules orally QD on Days 1-21 of Cycles 1-6 (1 cycle = 28 days) along with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1-6 and polatuzumab vedotin, 1.8 mg/kg, as an IV infusion on Day 1 of Cycles 1 to 6, as induction treatment. Thereafter participants who achieved CR or PR at EOI received consolidation treatment until disease progression or unacceptable toxicity for up to 6 months. During consolidation treatment, participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 6 months, and rituximab, 375 mg/m\^2 IV on Day 1 of every other month for up to 6 months.	Expansion Phase: 1.4 mg Pola + 20 mg L + 1000 mg G in FL n=40 participants at risk Participants with FL received lenalidomide, 20 mg capsules orally QD on Days 1-21 of Cycles 1 to 6 (1 cycle = 28 days) along with obinutuzumab, 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6, and polatuzumab vedotin, 1.4 mg/kg, IV infusion on Day 1 of Cycles 1-6, as induction treatment. Thereafter participants who achieved CR, PR, or SD at EOI received maintenance treatment until disease progression or unacceptable toxicity for up to 24 months. During maintenance treatment participants received lenalidomide, 10 mg, capsules, orally, QD on Days 1-21 of each month (1 month = 28 days) for up to 12 months, and obinutuzumab, 1000 mg IV on Day 1 of every other month for up to 24 months.
Infections and infestations PNEUMONIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations RESPIRATORY TRACT INFECTION	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	17.5% 7/40 • Number of events 13 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations RHINITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations SINUSITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Blood and lymphatic system disorders ANAEMIA	35.9% 14/39 • Number of events 22 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	50.0% 3/6 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	40.0% 2/5 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	50.0% 5/10 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	45.0% 18/40 • Number of events 29 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Blood and lymphatic system disorders LEUKOPENIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Blood and lymphatic system disorders LYMPHOPENIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Blood and lymphatic system disorders NEUTROPENIA	64.1% 25/39 • Number of events 62 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	50.0% 2/4 • Number of events 9 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 8 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	100.0% 6/6 • Number of events 18 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	66.7% 2/3 • Number of events 7 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	60.0% 3/5 • Number of events 7 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	70.0% 7/10 • Number of events 15 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	65.0% 26/40 • Number of events 117 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Blood and lymphatic system disorders NEUTROPHILIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Blood and lymphatic system disorders THROMBOCYTOPENIA	25.6% 10/39 • Number of events 18 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	50.0% 2/4 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	83.3% 5/6 • Number of events 10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	55.0% 22/40 • Number of events 50 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Ear and labyrinth disorders TYMPANIC MEMBRANE PERFORATION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Ear and labyrinth disorders VERTIGO	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Endocrine disorders DIABETES INSIPIDUS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Eye disorders DRY EYE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Eye disorders OCULAR HYPERAEMIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Eye disorders PERIORBITAL OEDEMA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Eye disorders VISION BLURRED	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders ABDOMINAL DISTENSION	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders ABDOMINAL PAIN	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	15.0% 6/40 • Number of events 6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders ASCITES	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders CONSTIPATION	20.5% 8/39 • Number of events 8 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	40.0% 2/5 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	17.5% 7/40 • Number of events 10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders DENTAL CARIES	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders DIARRHOEA	33.3% 13/39 • Number of events 23 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	66.7% 2/3 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	50.0% 2/4 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	66.7% 2/3 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	42.5% 17/40 • Number of events 24 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders DRY MOUTH	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders DYSPEPSIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders DYSPHAGIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders FLATULENCE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders GASTRITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders MELAENA	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders NAUSEA	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	66.7% 2/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 8/40 • Number of events 10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders ODYNOPHAGIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders TOOTHACHE	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders UMBILICAL HERNIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Gastrointestinal disorders VOMITING	10.3% 4/39 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders ASTHENIA	15.4% 6/39 • Number of events 6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	50.0% 2/4 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	17.5% 7/40 • Number of events 12 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders CHILLS	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders FATIGUE	15.4% 6/39 • Number of events 6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	66.7% 2/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	27.5% 11/40 • Number of events 11 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders FEELING ABNORMAL	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders GAIT DISTURBANCE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders OEDEMA PERIPHERAL	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders PAIN	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders PERIPHERAL SWELLING	7.7% 3/39 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
General disorders PYREXIA	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	66.7% 2/3 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	66.7% 2/3 • Number of events 6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	32.5% 13/40 • Number of events 17 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Hepatobiliary disorders OCULAR ICTERUS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Immune system disorders CYTOKINE RELEASE SYNDROME	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Immune system disorders HYPOGAMMAGLOBULINAEMIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations BRONCHITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations CANDIDA INFECTION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations CONJUNCTIVITIS	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations CYTOMEGALOVIRUS INFECTION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations GASTROENTERITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations HERPES ZOSTER	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations INFLUENZA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations NASOPHARYNGITIS	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 8/40 • Number of events 11 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations ORAL CANDIDIASIS	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations ORAL HERPES	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations TONSILLITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	15.0% 6/40 • Number of events 9 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION BACTERIAL	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Infections and infestations URINARY TRACT INFECTION	10.3% 4/39 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications FALL	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 2/6 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	42.5% 17/40 • Number of events 19 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Injury, poisoning and procedural complications MUSCLE STRAIN	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations ALANINE AMINOTRANSFERASE INCREASED	12.8% 5/39 • Number of events 8 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	40.0% 2/5 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 8/40 • Number of events 11 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations AMYLASE INCREASED	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	10.3% 4/39 • Number of events 8 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 7 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations BLOOD BILIRUBIN INCREASED	5.1% 2/39 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 12 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations BLOOD CREATININE INCREASED	7.7% 3/39 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	50.0% 2/4 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations BLOOD LACTATE DEHYDROGENASE DECREASED	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations C-REACTIVE PROTEIN INCREASED	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations CARDIAC STRESS TEST ABNORMAL	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations CREATININE RENAL CLEARANCE DECREASED	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations CREATININE RENAL CLEARANCE INCREASED	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	7.7% 3/39 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations IMMUNOGLOBULINS DECREASED	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations LIPASE INCREASED	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations TRANSAMINASES INCREASED	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Investigations WEIGHT DECREASED	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders DECREASED APPETITE	15.4% 6/39 • Number of events 6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 8/40 • Number of events 8 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders DEHYDRATION	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders DYSLIPIDAEMIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders GOUT	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPERGLYCAEMIA	10.3% 4/39 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPERURICAEMIA	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPOCALCAEMIA	10.3% 4/39 • Number of events 7 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPOKALAEMIA	10.3% 4/39 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	12.8% 5/39 • Number of events 9 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 13 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPONATRAEMIA	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders HYPOPROTEINAEMIA	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders ARTHRALGIA	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 2/6 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	17.5% 7/40 • Number of events 9 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders ARTHRITIS	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders BACK PAIN	15.4% 6/39 • Number of events 7 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders DIASTASIS RECTI ABDOMINIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 7 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders NECK PAIN	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	30.0% 3/10 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders SACRAL PAIN	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Musculoskeletal and connective tissue disorders TENDONITIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR FLARE	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders BURNING SENSATION	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders DIZZINESS	7.7% 3/39 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 7 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders DYSGEUSIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders HEAD TITUBATION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders HEADACHE	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders NEURALGIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders NEUROPATHY PERIPHERAL	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 2/10 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders PARAESTHESIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders RESTING TREMOR	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Nervous system disorders SYNCOPE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Psychiatric disorders DEPRESSION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Psychiatric disorders INSOMNIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Renal and urinary disorders ACUTE KIDNEY INJURY	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Renal and urinary disorders DYSURIA	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Renal and urinary disorders HAEMATURIA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Renal and urinary disorders RENAL FAILURE	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Reproductive system and breast disorders VULVOVAGINAL DRYNESS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders COUGH	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	50.0% 3/6 • Number of events 7 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 10/40 • Number of events 11 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 12 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Respiratory, thoracic and mediastinal disorders UPPER-AIRWAY COUGH SYNDROME	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders DRY SKIN	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	2.5% 1/40 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders DYSHIDROTIC ECZEMA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders PETECHIAE	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders PRURITUS	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	20.0% 1/5 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 4/40 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders RASH	17.9% 7/39 • Number of events 10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	66.7% 2/3 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	40.0% 4/10 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	12.5% 5/40 • Number of events 5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	7.7% 3/39 • Number of events 4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	7.5% 3/40 • Number of events 3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders SKIN EXFOLIATION	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	10.0% 1/10 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	25.0% 1/4 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Vascular disorders FLUSHING	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	5.0% 2/40 • Number of events 2 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Vascular disorders HYPERTENSION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	33.3% 1/3 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/6 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.00% 0/39 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/4 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/3 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/5 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/10 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.	0.00% 0/40 • From Baseline up to study completion/discontinuation (maximum of 69 months) The safety-evaluable population was defined as all participants who received at least one dose of any component of the combination.

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