Trial Outcomes & Findings for A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants (NCT NCT02624986)

Last Updated: 2020-05-18

Results Overview

The plan was for the IRC to evaluate responses at the end of induction treatment in participants from the expansion phase using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[≤\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)

Results posted on

2020-05-18

Participant Flow

A total of 45 patients were screened, twenty-five of whom were enrolled in the dose escalation phase. The sponsor decided to terminate the study early and the expansion phase was not opened.

Participant milestones

Participant milestones
Measure	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).
Overall Study STARTED	2	3	2	3	4	2	4	5
Overall Study Received Any Study Treatment	1	3	2	3	4	2	4	5
Overall Study COMPLETED	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	2	3	2	3	4	2	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).
Overall Study Death	0	1	2	2	2	0	0	1
Overall Study Study Terminated by Sponsor	1	1	0	1	2	2	4	3
Overall Study Progressive Disease	0	1	0	0	0	0	0	0
Overall Study Protocol Violation	1	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	1

Baseline Characteristics

A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	Total n=25 Participants Total of all reporting groups
Age, Continuous	62.5 Years STANDARD_DEVIATION 6.4 • n=5 Participants	70.7 Years STANDARD_DEVIATION 15.2 • n=7 Participants	55.5 Years STANDARD_DEVIATION 10.6 • n=5 Participants	67.3 Years STANDARD_DEVIATION 8.4 • n=4 Participants	56.5 Years STANDARD_DEVIATION 12.9 • n=21 Participants	52.5 Years STANDARD_DEVIATION 6.4 • n=8 Participants	53.3 Years STANDARD_DEVIATION 6.7 • n=8 Participants	64.2 Years STANDARD_DEVIATION 9.8 • n=24 Participants	60.6 Years STANDARD_DEVIATION 10.8 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	4 Participants n=24 Participants	12 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	13 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	5 Participants n=24 Participants	23 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	6 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	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	0 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	5 Participants n=24 Participants	17 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants

PRIMARY outcome

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

Population: The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Phase 2), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycles 1, 2 (1 cycle is 28 days)

Population: Safety Population: participants who received at least one dose of any study drug.

A dose-limiting toxicity (DLT) was defined as at least one of the following events occurring during Cycle 1 (or first 2 cycles in the bridging FL cohort) of treatment and assessed by the investigator as not clearly related to the underlying disease: Any Grade 5 adverse event (AE; severity graded per NCI-CTCAE v4.0) unless due to the underlying malignancy or extraneous causes; AE of any grade that leads to a delay of more than (\>)14 days in the start of the next treatment cycle; Grade 3 or 4 non-hematologic AEs (with exceptions); Lab results suggestive of potential drug-induced liver injury (according to Hy's law); Grade 3 or 4 neutropenia in the presence of sustained fever of \>38 C (lasting \>5 days) or a documented infection; Grade 4 neutropenia or thrombocytopenia lasting \>7 days; Grade 3 or 4 thrombocytopenia if associated with Grade ≥3 bleeding; Other toxicities considered clinically relevant and related to study treatment as determined by the investigator and medical monitor.

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Number of Participants With a Dose-Limiting Toxicity Any DLT	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With a Dose-Limiting Toxicity Thrombocytopenia	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

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

Population: ITT Population: all enrolled participants; exploratory analysis of the dose escalation phase (Phase 1). The study plan was for efficacy analyses to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) and the study was terminated early.

The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[≤\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria	33.3 Percentage of participants Interval 1.7 to 86.46	0 Percentage of participants Interval 0.0 to 77.64	0 Percentage of participants Interval 0.0 to 63.16	0 Percentage of participants Interval 0.0 to 52.71	50.0 Percentage of participants Interval 2.53 to 97.47	0 Percentage of participants Interval 0.0 to 52.71	40.0 Percentage of participants Interval 7.64 to 81.07	0 Percentage of participants Interval 0.0 to 77.64

SECONDARY outcome

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

The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to \[≤\] mediastinum; 3 = uptake greater than \[\>\] mediastinum and ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly \> liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma). The CR criteria for participants with bone marrow involvement at screening required no evidence of FDG-avid disease in the marrow. PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria	33.3 Percentage of participants Interval 1.7 to 86.46	0 Percentage of participants Interval 0.0 to 77.64	0 Percentage of participants Interval 0.0 to 63.16	0 Percentage of participants Interval 0.0 to 52.71	50.0 Percentage of participants Interval 2.53 to 97.47	0 Percentage of participants Interval 0.0 to 52.71	40.0 Percentage of participants Interval 7.64 to 81.07	0 Percentage of participants Interval 0.0 to 77.64

SECONDARY outcome

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

The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion \[LDi\]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

The investigator evaluated responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion \[LDi\]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria	33.3 Percentage of participants Interval 1.7 to 86.46	0 Percentage of participants Interval 0.0 to 77.64	0 Percentage of participants Interval 0.0 to 63.16	0 Percentage of participants Interval 0.0 to 52.71	0 Percentage of participants Interval 0.0 to 77.64	0 Percentage of participants Interval 0.0 to 52.71	20.0 Percentage of participants Interval 1.02 to 65.74	0 Percentage of participants Interval 0.0 to 77.64

SECONDARY outcome

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

The IRC was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: The study plan was for this efficacy analysis to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).

The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 \[no uptake above background\] to 5 \[uptake markedly higher than liver and/or new lesions\]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

The investigator was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Cycle 2, end of induction (up to 6 cycles; 1 cycle is 28 days), every 2 months (FL) until end of maintenance or at 4 months (DLBCL) of consolidation treatment, and then every 6 months during follow-up until disease progression (up to 3.5 years)

The investigator was to evaluate responses throughout the study using the Lugano 2014 response criteria for malignant lymphoma for a CT-based best response of a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by \>50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose (0 hours) and 6 hours postdose on Day 1 of Cycles 1, 2, and 4; Predose (0 hours) and 2, 4, 6, and 24 hours postdose on Day 5 of Cycles 1 and 2; Predose (0 hours) and 6 and 24 hours postdose on Cycle 4, Day 5 (1 cycle is 28 days)

Population: Pharmacokinetics Evaluable Population: all participants who received at least one dose of study drug. For this analysis, FL and DLBCL participants are grouped by idasanutlin dose and combination drug (obinutuzumab or rituximab). The number analyzed includes participants who were evaluable at each timepoint.

The concentration of idasanutlin was determined using a validated assay. The duplication of the predose timepoint (0 hours) on Day 5 as an additional 24-hour timepoint on Day 5 was done in order to conduct pharmacokinetics analysis via non-compartmental analysis, and to derive idasanutlin exposure estimates up to the 24-hour post Day 5 dosing.

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=12 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 1, Day 1: 0 hours	0 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 0	0 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 0	0 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 0	0 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 0	—	—	—	0 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 0
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 1, Day 1: 6 hours	2210 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 42.4	5540 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 21.5	2130 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 91.3	2980 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 49.9	—	—	—	1540 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 21.6
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 1, Day 5: 0 hours	2150 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 46.4	4120 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 27.3	1660 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 77.9	2920 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 56.8	—	—	—	1150 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 19.9
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 1, Day 5: 2 hours	3570 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 68.4	7850 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 23	2970 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 53.2	4970 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 45.7	—	—	—	1230 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 20.8
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 1, Day 5: 4 hours	4360 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 67.6	7930 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 15.5	2910 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 73.2	5910 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 54.6	—	—	—	1670 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 17.5
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 1, Day 5: 6 hours	4220 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 94.8	7310 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 13.6	2820 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 68.7	5200 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 49.8	—	—	—	1730 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 15.5
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 1, Day 5: 24 hours	2150 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 46.4	4120 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 27.3	1660 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 77.9	2920 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 56.8	—	—	—	1150 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 19.9
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 2, Day 1: 0 hours	0 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 0	—	0 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 0	—	—	—	—	0 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 0
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 2, Day 1: 6 hours	2480 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 51.5	—	1260 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 49.8	—	—	—	—	1660 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 33.1
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 2, Day 5: 0 hours	2380 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 27.2	—	2400 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 67	—	—	—	—	—
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 2, Day 5: 2 hours	4050 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 54.9	—	—	—	—	—	—	—
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 2, Day 5: 4 hours	4200 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 38.2	—	—	—	—	—	—	—
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 2, Day 5: 6 hours	4010 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 31.6	—	—	—	—	—	—	—
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 2, Day 5: 24 hours	2380 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 27.2	—	—	—	—	—	—	—
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 4, Day 1: 0 hours	0 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 0	—	—	—	—	—	—	—
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 4, Day 1: 6 hours	2730 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 9.9	—	—	—	—	—	—	—
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 4, Day 5: 0 hours	2600 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 25.6	—	—	—	—	—	—	—
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 4, Day 5: 6 hours	5210 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 19.5	—	—	—	—	—	—	—
Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab) Cycle 4, Day 5: 24 hours	2600 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 25.6	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion (0 hour) and 0.5 hours after end of obinutuzumab infusion on Day 1 of Cycles 1, 2, 4, and 6

Population: Pharmacokinetics Evaluable Population: all participants who received at least one dose of study drug. This analysis only includes FL and DLBCL participants who received obinutuzumab. The number analyzed includes participants who were evaluable at each timepoint.

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=17 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Cycle 1, Day 1: 0 hours	—	—	—	—	—	—	—	0 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 0
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Cycle 1, Day 1: 0.5 hours	—	—	—	—	—	—	—	397 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 32.9
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Cycle 2, Day 1: 0 hours	—	—	—	—	—	—	—	325 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 59.8
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Cycle 2, Day 1: 0.5 hours	—	—	—	—	—	—	—	703 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 40.2
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Cycle 4, Day 1: 0 hours	—	—	—	—	—	—	—	346 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 46.1
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Cycle 4, Day 1: 0.5 hours	—	—	—	—	—	—	—	685 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 38.5
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Cycle 6, Day 1: 0 hours	—	—	—	—	—	—	—	303 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 49.5
Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Cycle 6, Day 1: 0.5 hours	—	—	—	—	—	—	—	639 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 34.2

SECONDARY outcome

Timeframe: Pre-infusion (0 hours) at Cycle 1, Day 1 and Cycle 2, Day 1; Post-infusion 0.5 hours at Cycle 1, Day 1 (1 cycle is 28 days)

Population: Pharmacokinetics Evaluable Population: all participants who received at least one dose of study drug. This analysis only includes DLBCL participants who received rituximab. The number analyzed includes participants who were evaluable at each timepoint.

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=7 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints Cycle 1, Day 1: 0 hours	—	—	—	—	—	—	—	0 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 0
Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints Cycle 1, Day 1: 0.5 hours	—	—	—	—	—	—	—	197 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 14.1
Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints Cycle 2, Day 1: 0 hours	—	—	—	—	—	—	—	37.9 micrograms per millilitre (μg/mL) Geometric Coefficient of Variation 58.1

SECONDARY outcome

Timeframe: From first dose until 90 days after the last dose of study drug treatment (up to 31 months)

Population: Safety Population: participants who received at least one dose of any component of the combination treatment.

The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Any Adverse Event (AE)	3 Participants	2 Participants	3 Participants	4 Participants	2 Participants	4 Participants	5 Participants	1 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Grade 5 AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Grade 3-5 AE	3 Participants	2 Participants	2 Participants	3 Participants	1 Participants	3 Participants	4 Participants	1 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Serious AE	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) AE Leading to any Study Treatment Discontinuation	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) AE Leading to Dose Reductions	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) AE Leading to Dose Interruptions	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	1 Participants	1 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) AE Leading to Study Discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related to Idasanutlin - Any AE	2 Participants	2 Participants	2 Participants	4 Participants	1 Participants	4 Participants	5 Participants	1 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related to Idasanutlin - Grade 3-5 AE	2 Participants	2 Participants	1 Participants	2 Participants	1 Participants	3 Participants	4 Participants	1 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related to Idasanutlin - Serious AE	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related to Obinutuzumab - Any AE	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants	3 Participants	5 Participants	1 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related to Obinutuzumab - Grade 3-5 AE	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants	1 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related to Obinutuzumab - Serious AE	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related to Rituximab - Any AE	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related to Rituximab - Grade 3-5 AE	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related AE Leading to Treatment Discontinuation	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0) Related to Rituximab - Serious AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6 (up to 6 cycles; 1 cycle is 28 days), and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (up to 29 months)

Population: Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.

Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Baseline (BL) - Value at Visit	124.0 millimeters of mercury (mmHg) Standard Deviation 7.9	107.5 millimeters of mercury (mmHg) Standard Deviation 2.1	125.7 millimeters of mercury (mmHg) Standard Deviation 39.4	119.0 millimeters of mercury (mmHg) Standard Deviation 16.8	120.5 millimeters of mercury (mmHg) Standard Deviation 17.7	109.3 millimeters of mercury (mmHg) Standard Deviation 9.1	116.4 millimeters of mercury (mmHg) Standard Deviation 10.5	176.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Cycle 1 Day 15	-5.3 millimeters of mercury (mmHg) Standard Deviation 14.6	—	—	—	-3.5 millimeters of mercury (mmHg) Standard Deviation 7.8	9.7 millimeters of mercury (mmHg) Standard Deviation 13.4	8.0 millimeters of mercury (mmHg) Standard Deviation 12.9	24.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Cycle 2 Day 1	-3.5 millimeters of mercury (mmHg) Standard Deviation 19.1	—	0.0 millimeters of mercury (mmHg) Standard Deviation 39.6	—	-14.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	4.5 millimeters of mercury (mmHg) Standard Deviation 4.9	8.6 millimeters of mercury (mmHg) Standard Deviation 10.4	-17.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Cycle 3 Day 1	11.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—	-13.5 millimeters of mercury (mmHg) Standard Deviation 3.5	10.5 millimeters of mercury (mmHg) Standard Deviation 2.1	7.0 millimeters of mercury (mmHg) Standard Deviation 8.9	-1.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Cycle 4 Day 1	—	—	—	—	12.5 millimeters of mercury (mmHg) Standard Deviation 27.6	2.0 millimeters of mercury (mmHg) Standard Deviation 1.4	-10.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	-22.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Cycle 5 Day 1	—	—	—	—	0.5 millimeters of mercury (mmHg) Standard Deviation 4.9	12.5 millimeters of mercury (mmHg) Standard Deviation 9.2	8.5 millimeters of mercury (mmHg) Standard Deviation 9.2	-21.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Cycle 6 Day 1	—	—	—	—	-2.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	20.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	0.5 millimeters of mercury (mmHg) Standard Deviation 0.7	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 1	—	—	—	—	-14.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	14.0 millimeters of mercury (mmHg) Standard Deviation 9.9	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 3	—	—	—	—	9.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	7.5 millimeters of mercury (mmHg) Standard Deviation 10.6	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 5	—	—	—	—	-12.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	9.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 7	—	—	—	—	-5.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	0.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 9	—	—	—	—	-3.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	7.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 11	—	—	—	—	-5.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 13	—	—	—	—	-5.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 15	—	—	—	—	-9.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 17	—	—	—	—	-35.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 21	—	—	—	—	-21.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Follow-Up	—	-3.5 millimeters of mercury (mmHg) Standard Deviation 9.2	-25.0 millimeters of mercury (mmHg) Standard Deviation 55.2	-3.5 millimeters of mercury (mmHg) Standard Deviation 0.7	9.5 millimeters of mercury (mmHg) Standard Deviation 3.5	20.0 millimeters of mercury (mmHg) Standard Deviation 15.5	-1.3 millimeters of mercury (mmHg) Standard Deviation 9.0	-32.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Cycle 1 Day 8	-5.0 millimeters of mercury (mmHg) Standard Deviation 8.5	-7.0 millimeters of mercury (mmHg) Standard Deviation 8.5	—	—	-6.5 millimeters of mercury (mmHg) Standard Deviation 6.4	-2.3 millimeters of mercury (mmHg) Standard Deviation 15.2	6.4 millimeters of mercury (mmHg) Standard Deviation 10.3	-4.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Cycle 1 Day 1	-2.0 millimeters of mercury (mmHg) Standard Deviation 10.5	-5.0 millimeters of mercury (mmHg) Standard Deviation 4.2	-2.7 millimeters of mercury (mmHg) Standard Deviation 14.6	-0.8 millimeters of mercury (mmHg) Standard Deviation 10.6	-3.5 millimeters of mercury (mmHg) Standard Deviation 10.6	3.5 millimeters of mercury (mmHg) Standard Deviation 9.4	4.8 millimeters of mercury (mmHg) Standard Deviation 14.8	-34.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 19	—	—	—	—	2.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Cycle 6 Day 1	—	—	—	—	10.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	9.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	2.5 millimeters of mercury (mmHg) Standard Deviation 3.5	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Cycle 1 Day 1	-2.0 millimeters of mercury (mmHg) Standard Deviation 19.5	-2.5 millimeters of mercury (mmHg) Standard Deviation 2.1	7.3 millimeters of mercury (mmHg) Standard Deviation 23.1	-2.3 millimeters of mercury (mmHg) Standard Deviation 7.4	-2.0 millimeters of mercury (mmHg) Standard Deviation 4.2	3.0 millimeters of mercury (mmHg) Standard Deviation 4.9	6.4 millimeters of mercury (mmHg) Standard Deviation 2.1	-17.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Cycle 1 Day 8	1.3 millimeters of mercury (mmHg) Standard Deviation 15.0	-2.5 millimeters of mercury (mmHg) Standard Deviation 6.4	—	—	-2.0 millimeters of mercury (mmHg) Standard Deviation 0.0	-6.5 millimeters of mercury (mmHg) Standard Deviation 1.3	9.2 millimeters of mercury (mmHg) Standard Deviation 8.5	-1.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Cycle 1 Day 15	3.0 millimeters of mercury (mmHg) Standard Deviation 16.4	—	—	—	6.0 millimeters of mercury (mmHg) Standard Deviation 4.2	0.0 millimeters of mercury (mmHg) Standard Deviation 6.6	2.4 millimeters of mercury (mmHg) Standard Deviation 8.3	-1.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Cycle 2 Day 1	0.0 millimeters of mercury (mmHg) Standard Deviation 17.0	—	3.5 millimeters of mercury (mmHg) Standard Deviation 13.4	—	0.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	-8.0 millimeters of mercury (mmHg) Standard Deviation 2.8	12.0 millimeters of mercury (mmHg) Standard Deviation 5.1	7.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Cycle 3 Day 1	3.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—	-5.5 millimeters of mercury (mmHg) Standard Deviation 6.4	-1.0 millimeters of mercury (mmHg) Standard Deviation 4.2	5.3 millimeters of mercury (mmHg) Standard Deviation 5.0	3.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 1	—	—	—	—	0.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	2.0 millimeters of mercury (mmHg) Standard Deviation 0.0	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 3	—	—	—	—	14.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	5.0 millimeters of mercury (mmHg) Standard Deviation 8.5	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 5	—	—	—	—	-7.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-5.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 7	—	—	—	—	7.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-1.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 9	—	—	—	—	6.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	3.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 13	—	—	—	—	1.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 15	—	—	—	—	9.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Follow-Up	—	-9.0 millimeters of mercury (mmHg) Standard Deviation 21.2	-15.5 millimeters of mercury (mmHg) Standard Deviation 20.5	4.0 millimeters of mercury (mmHg) Standard Deviation 4.2	10.5 millimeters of mercury (mmHg) Standard Deviation 2.1	7.5 millimeters of mercury (mmHg) Standard Deviation 20.2	9.3 millimeters of mercury (mmHg) Standard Deviation 3.3	-16.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Cycle 5 Day 1	—	—	—	—	3.5 millimeters of mercury (mmHg) Standard Deviation 0.7	-2.0 millimeters of mercury (mmHg) Standard Deviation 7.1	2.5 millimeters of mercury (mmHg) Standard Deviation 4.9	-2.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Baseline (BL) - Value at Visit	67.3 millimeters of mercury (mmHg) Standard Deviation 12.1	72.0 millimeters of mercury (mmHg) Standard Deviation 9.9	72.3 millimeters of mercury (mmHg) Standard Deviation 12.3	70.3 millimeters of mercury (mmHg) Standard Deviation 7.6	71.5 millimeters of mercury (mmHg) Standard Deviation 9.2	76.3 millimeters of mercury (mmHg) Standard Deviation 12.7	65.8 millimeters of mercury (mmHg) Standard Deviation 6.9	100.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Cycle 4 Day 1	—	—	—	—	3.0 millimeters of mercury (mmHg) Standard Deviation 8.5	-8.0 millimeters of mercury (mmHg) Standard Deviation 7.1	7.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	-4.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 11	—	—	—	—	-13.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 17	—	—	—	—	-4.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 19	—	—	—	—	7.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints Change from BL at Maint. Month 21	—	—	—	—	0.0 millimeters of mercury (mmHg) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Baseline (BL) - Value at Visit	65.7 beats per minute Standard Deviation 1.2	100.5 beats per minute Standard Deviation 17.7	81.7 beats per minute Standard Deviation 3.1	76.0 beats per minute Standard Deviation 10.6	77.5 beats per minute Standard Deviation 12.0	79.5 beats per minute Standard Deviation 18.6	80.2 beats per minute Standard Deviation 9.9	73.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Cycle 1 Day 1	15.7 beats per minute Standard Deviation 21.5	-9.0 beats per minute Standard Deviation 8.5	0.0 beats per minute Standard Deviation 9.8	8.8 beats per minute Standard Deviation 12.0	2.5 beats per minute Standard Deviation 14.8	2.3 beats per minute Standard Deviation 6.4	9.0 beats per minute Standard Deviation 11.1	10.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Cycle 1 Day 8	11.0 beats per minute Standard Deviation 2.0	-2.0 beats per minute Standard Deviation 1.4	—	—	-0.5 beats per minute Standard Deviation 20.5	2.3 beats per minute Standard Deviation 6.4	9.0 beats per minute Standard Deviation 11.1	-2.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Cycle 1 Day 15	12.7 beats per minute Standard Deviation 13.4	—	—	—	-3.5 beats per minute Standard Deviation 16.3	-1.7 beats per minute Standard Deviation 13.1	3.2 beats per minute Standard Deviation 14.5	-11.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Cycle 2 Day 1	17.5 beats per minute Standard Deviation 17.7	—	7.0 beats per minute Standard Deviation 1.4	—	-17.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	-2.5 beats per minute Standard Deviation 4.9	6.4 beats per minute Standard Deviation 9.7	4.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Cycle 3 Day 1	19.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—	-1.5 beats per minute Standard Deviation 16.3	-4.5 beats per minute Standard Deviation 20.5	-3.5 beats per minute Standard Deviation 10.6	-1.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Cycle 4 Day 1	—	—	—	—	-7.0 beats per minute Standard Deviation 12.7	-5.0 beats per minute Standard Deviation 5.7	4.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	1.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Cycle 5 Day 1	—	—	—	—	-6.5 beats per minute Standard Deviation 10.6	3.0 beats per minute Standard Deviation 28.3	6.5 beats per minute Standard Deviation 4.9	15.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Cycle 6 Day 1	—	—	—	—	-1.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	31.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	15.0 beats per minute Standard Deviation 2.8	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 1	—	—	—	—	6.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	10.0 beats per minute Standard Deviation 5.7	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 3	—	—	—	—	0.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	2.0 beats per minute Standard Deviation 9.9	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 5	—	—	—	—	-5.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	11.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 7	—	—	—	—	1.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	2.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Follow-Up	—	-20.0 beats per minute Standard Deviation 18.4	11.5 beats per minute Standard Deviation 10.6	23.5 beats per minute Standard Deviation 20.5	15.0 beats per minute Standard Deviation 8.5	5.8 beats per minute Standard Deviation 14.8	10.3 beats per minute Standard Deviation 9.2	15.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 9	—	—	—	—	6.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	11.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 11	—	—	—	—	18.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 13	—	—	—	—	11.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 15	—	—	—	—	2.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 17	—	—	—	—	-2.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 19	—	—	—	—	1.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints Change from BL at Maint. Month 21	—	—	—	—	13.0 beats per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 17	—	—	—	—	2.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 19	—	—	—	—	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Follow-Up	—	-2.0 breaths per minute Standard Deviation 2.8	-4.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	0.0 breaths per minute Standard Deviation 2.8	1.0 breaths per minute Standard Deviation 1.4	3.3 breaths per minute Standard Deviation 3.2	-0.7 breaths per minute Standard Deviation 3.1	-2.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Baseline (BL) - Value at Visit	17.0 breaths per minute Standard Deviation 2.6	19.0 breaths per minute Standard Deviation 1.4	17.0 breaths per minute Standard Deviation 1.7	17.0 breaths per minute Standard Deviation 2.0	16.0 breaths per minute Standard Deviation 0.0	16.0 breaths per minute Standard Deviation 3.3	16.8 breaths per minute Standard Deviation 3.0	18.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Cycle 1 Day 1	0.7 breaths per minute Standard Deviation 1.2	-1.0 breaths per minute Standard Deviation 1.4	-0.7 breaths per minute Standard Deviation 1.2	0.3 breaths per minute Standard Deviation 1.3	1.0 breaths per minute Standard Deviation 1.4	2.3 breaths per minute Standard Deviation 0.5	0.0 breaths per minute Standard Deviation 0.0	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Cycle 1 Day 8	-1.7 breaths per minute Standard Deviation 2.1	-1.0 breaths per minute Standard Deviation 1.4	—	—	0.0 breaths per minute Standard Deviation 0.0	2.0 breaths per minute Standard Deviation 4.0	0.0 breaths per minute Standard Deviation 2.4	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Cycle 1 Day 15	-3.5 breaths per minute Standard Deviation 2.1	—	—	—	1.0 breaths per minute Standard Deviation 1.4	1.7 breaths per minute Standard Deviation 1.5	-0.2 breaths per minute Standard Deviation 2.7	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Cycle 2 Day 1	-2.5 breaths per minute Standard Deviation 3.5	—	0.5 breaths per minute Standard Deviation 0.7	—	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	4.0 breaths per minute Standard Deviation 5.7	0.0 breaths per minute Standard Deviation 4.6	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Cycle 3 Day 1	-4.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—	0.0 breaths per minute Standard Deviation 0.0	4.0 breaths per minute Standard Deviation 5.7	-1.0 breaths per minute Standard Deviation 4.2	2.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Cycle 4 Day 1	—	—	—	—	0.0 breaths per minute Standard Deviation 0.0	2.0 breaths per minute Standard Deviation 2.8	4.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	-2.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Cycle 5 Day 1	—	—	—	—	0.0 breaths per minute Standard Deviation 0.0	1.0 breaths per minute Standard Deviation 1.4	0.0 breaths per minute Standard Deviation 5.7	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Cycle 6 Day 1	—	—	—	—	-4.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	5.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	-2.0 breaths per minute Standard Deviation 2.8	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 1	—	—	—	—	-4.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-1.0 breaths per minute Standard Deviation 4.2	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 3	—	—	—	—	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-2.0 breaths per minute Standard Deviation 2.8	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 5	—	—	—	—	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-4.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 7	—	—	—	—	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-4.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 9	—	—	—	—	2.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-4.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 11	—	—	—	—	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 13	—	—	—	—	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 15	—	—	—	—	0.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints Change from BL at Maint. Month 21	—	—	—	—	2.0 breaths per minute Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Baseline (BL) - Value at Visit	36.47 degrees Celsius (C) Standard Deviation 0.45	36.35 degrees Celsius (C) Standard Deviation 0.21	36.83 degrees Celsius (C) Standard Deviation 0.15	36.58 degrees Celsius (C) Standard Deviation 0.34	36.55 degrees Celsius (C) Standard Deviation 0.21	36.50 degrees Celsius (C) Standard Deviation 0.18	36.70 degrees Celsius (C) Standard Deviation 3.3	36.60 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Cycle 1 Day 1	0.00 degrees Celsius (C) Standard Deviation 0.92	-0.15 degrees Celsius (C) Standard Deviation 0.21	-0.07 degrees Celsius (C) Standard Deviation 0.15	0.18 degrees Celsius (C) Standard Deviation 0.33	0.05 degrees Celsius (C) Standard Deviation 0.49	0.30 degrees Celsius (C) Standard Deviation 0.22	-0.18 degrees Celsius (C) Standard Deviation 0.30	0.00 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Cycle 1 Day 8	0.37 degrees Celsius (C) Standard Deviation 0.50	0.95 degrees Celsius (C) Standard Deviation 0.85	—	—	0.30 degrees Celsius (C) Standard Deviation 0.28	-0.13 degrees Celsius (C) Standard Deviation 0.22	0.10 degrees Celsius (C) Standard Deviation 0.45	0.10 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Cycle 1 Day 15	0.20 degrees Celsius (C) Standard Deviation 0.82	—	—	—	0.20 degrees Celsius (C) Standard Deviation 0.28	-0.23 degrees Celsius (C) Standard Deviation 0.45	-0.18 degrees Celsius (C) Standard Deviation 0.26	0.10 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Cycle 2 Day 1	0.10 degrees Celsius (C) Standard Deviation 0.14	—	-0.30 degrees Celsius (C) Standard Deviation 0.14	—	-0.50 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	-0.25 degrees Celsius (C) Standard Deviation 0.49	-0.04 degrees Celsius (C) Standard Deviation 0.09	0.00 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Cycle 3 Day 1	-0.10 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—	-0.10 degrees Celsius (C) Standard Deviation 0.42	-0.50 degrees Celsius (C) Standard Deviation 0.28	-0.17 degrees Celsius (C) Standard Deviation 0.21	-0.20 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Cycle 4 Day 1	—	—	—	—	0.05 degrees Celsius (C) Standard Deviation 0.64	0.05 degrees Celsius (C) Standard Deviation 0.21	-0.10 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	0.00 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Cycle 5 Day 1	—	—	—	—	0.35 degrees Celsius (C) Standard Deviation 0.64	-0.35 degrees Celsius (C) Standard Deviation 0.49	-0.20 degrees Celsius (C) Standard Deviation 0.14	0.20 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Cycle 6 Day 1	—	—	—	—	0.20 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	0.20 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	-0.05 degrees Celsius (C) Standard Deviation 0.21	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 1	—	—	—	—	0.60 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-0.20 degrees Celsius (C) Standard Deviation 0.14	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 3	—	—	—	—	0.40 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-0.20 degrees Celsius (C) Standard Deviation 0.57	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 5	—	—	—	—	0.20 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-0.20 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 7	—	—	—	—	0.60 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	-0.10 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 15	—	—	—	—	0.70 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 17	—	—	—	—	0.40 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 19	—	—	—	—	0.80 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Follow-Up	—	0.00 degrees Celsius (C) Standard Deviation 0.14	-0.40 degrees Celsius (C) Standard Deviation 0.14	0.53 degrees Celsius (C) Standard Deviation 0.71	0.30 degrees Celsius (C) Standard Deviation 0.57	-0.15 degrees Celsius (C) Standard Deviation 0.47	-0.10 degrees Celsius (C) Standard Deviation 0.24	0.10 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 9	—	—	—	—	0.30 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	0.20 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 11	—	—	—	—	0.70 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 13	—	—	—	—	0.40 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—
Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints Change from BL at Maint. Month 21	—	—	—	—	0.50 degrees Celsius (C) Standard Deviation NA Standard deviation could not be calculated from data for a single participant.	—	—	—

SECONDARY outcome

Timeframe: Baseline, Induction Cycle 1 Day 1 and Cycle 4 Day 1, End of Induction (up to 6 cycles; 1 cycle is 28 days); Every 2 months during maintenance treatment from Months 1-23; End of Maintenance (up to 24 months); Unscheduled Visits (as clinically indicated)

Single, resting, 12-lead ECG recordings were to be obtained after the participant had been resting in a supine position for at least 10 minutes. Any morphologic waveform changes or other ECG abnormalities were to be documented and clinical significance was determined based on the presence of symptoms, per the investigator's judgment. If the ECG assessment was missing at baseline then it was recorded as "Missing". The ECG results assessments are presented as the shift from baseline to post-baseline assessments at each timepoint. BL = baseline; Cyc1, D1 = Induction Cycle 1 Day 1; Cyc4, D1 = Induction Cycle 4 Day 1; CS = Clinically Significant; EOI = End of Induction Treatment - Completion/Discontinuation; EOM = End of Maintenance Treatment - Completion/Discontinuation; MM1 = Maintenance Month 1; Unsched = Unscheduled Visit

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Cyc1, D1: Normal (BL) to Normal	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	4 Participants	2 Participants	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Cyc1, D1: Normal (BL) to Abnormal, not CS	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Cyc1, D1: Abnormal, not CS (BL) to Normal	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Cyc1,D1: Abnormal, not CS (BL) to Abnormal, not CS	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Cyc4, D1: Normal (BL) to Normal	—	—	—	—	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Cyc4, D1: Normal (BL) to Abnormal, not CS	—	—	—	—	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Cyc4, D1: Abnormal, not CS (BL) to Normal	—	—	—	—	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Cyc4,D1: Abnormal, not CS (BL) to Abnormal, not CS	—	—	—	—	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Cyc4, D1: Missing (BL) to Normal	—	—	—	—	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints EOI: Normal (BL) to Normal	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	3 Participants	2 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints EOI: Normal (BL) to Abnormal, not CS	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints EOI: Abnormal, not CS (BL) to Abnormal, not CS	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints EOI: Missing (BL) to Normal	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM1: Abnormal, not CS (BL) to Abnormal, not CS	—	—	—	—	—	—	1 Participants	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM3: Abnormal, not CS (BL) to Normal	—	—	—	—	—	—	1 Participants	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM7: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	—	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM9: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	—	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM11: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	—	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM23: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	—	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints EOM: Normal (BL) to Normal	—	—	—	—	0 Participants	1 Participants	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints EOM: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	0 Participants	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Unsched: Normal (BL) to Normal	—	—	—	—	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Unsched: Normal (BL) to Abnormal, not CS	—	—	—	—	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Unsched: Abnormal, not CS (BL) to Normal	—	—	—	—	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Unsched: Abnormal, not CS (BL) to Abnormal, not CS	—	—	—	—	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints Unsched: Abnormal, not CS (BL) to Abnormal, CS	—	—	—	—	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM1: Normal (BL) to Normal	—	—	—	—	—	—	1 Participants	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM5: Abnormal, not CS (BL) to Normal	—	—	—	—	—	—	1 Participants	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM13: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	—	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM15: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	—	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM17: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	—	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM19: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	—	—	—
Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints MM21: Missing (BL) to Abnormal, not CS	—	—	—	—	1 Participants	—	—	—

SECONDARY outcome

Timeframe: From Baseline until 35 days after the last dose of study drug (up to 29 months)

Population: Safety Population: participants who received at least one dose of any component of the combination treatment.

Clinical laboratory tests for hematology parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. Abs. = absolute count; BL = baseline; WBC = white blood cell count

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), High: Grade (Gr.) 0 (BL) to 0	3 Participants	2 Participants	3 Participants	4 Participants	2 Participants	4 Participants	5 Participants	1 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), Low: Gr. 0 (BL) to 0	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), Low: Gr. 0 (BL) to 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), Low: Gr. 0 (BL) to 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), Low: Gr. 1 (BL) to 1	2 Participants	0 Participants	2 Participants	3 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), Low: Gr. 1 (BL) to 2	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), Low: Gr. 1 (BL) to 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), Low: Gr. 2 (BL) to 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), Low: Gr. 2 (BL) to 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Hemoglobin (g/L), Low: Gr. 3 (BL) to 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	3 Participants	4 Participants	2 Participants	4 Participants	5 Participants	1 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 0	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 1	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 2	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 0 (BL) to 4	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 1 (BL) to 3	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 4	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 3 (BL) to 4	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 4 (BL) to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 0	2 Participants	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 2	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 3	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Neutrophils,Total Abs (10^9/L),Low: Gr. 0(BL) to 4	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Neutrophils,Total Abs (10^9/L),Low: Gr. 2(BL) to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Platelets (10^9/L), Low: Gr. 0 (BL) to 0	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Platelets (10^9/L), Low: Gr. 1 (BL) to 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Platelets (10^9/L), Low: Gr. 1 (BL) to 3	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Platelets (10^9/L), Low: Gr. 1 (BL) to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	3 Participants	4 Participants	2 Participants	4 Participants	5 Participants	1 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), Low: Gr. 0 (BL) to 2	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), Low: Gr. 0 (BL) to 3	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), Low: Gr. 0 (BL) to 4	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), Low: Gr. 1 (BL) to 0	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), Low: Gr. 1 (BL) to 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), Low: Gr. 1 (BL) to 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), Low: Gr. 1 (BL) to 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Lymphocytes Abs. (10^9/L), Low: Gr. 2 (BL) to 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Platelets (10^9/L), Low: Gr. 0 (BL) to 1	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Platelets (10^9/L), Low: Gr. 0 (BL) to 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Platelets (10^9/L), Low: Gr. 0 (BL) to 3	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Platelets (10^9/L), Low: Gr. 0 (BL) to 4	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), Low: Gr. 0 (BL) to 0	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline WBC (10^9/L), Low: Gr. 0 (BL) to 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline until 35 days after the last dose of study drug (up to 29 months)

Population: Safety Population: participants who received at least one dose of any component of the combination treatment.

Clinical laboratory tests for blood chemistry parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. BL = Baseline; Blood Gluc., Fast. = blood glucose, fasting; SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase; Triacylglyc. Lipase = triacylglycerol lipase

Outcome measures

Outcome measures
Measure	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 Participants Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 Participants Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 0	3 Participants	2 Participants	1 Participants	2 Participants	2 Participants	4 Participants	3 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 1	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Albumin (g/L), Low: Grade (Gr.) 0 (BL) to 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Albumin (g/L), Low: Grade (Gr.) 1 (BL) to 1	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	2 Participants	3 Participants	1 Participants	4 Participants	3 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Alkaline Phosphatase (U/L), High: Gr. 0 (BL) to 1	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Alkaline Phosphatase (U/L), High: Gr. 1 (BL) to 1	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Amylase (U/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	3 Participants	1 Participants	2 Participants	3 Participants	5 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Amylase (U/L), High: Missing (BL) to Gr. 0	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Amylase (U/L), High: Gr. 1 (BL) to 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Bilirubin (umol/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	3 Participants	4 Participants	2 Participants	3 Participants	5 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Bilirubin (umol/L), High: Gr. 0 (BL) to 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 0	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Blood Gluc,Fast(mmol/L), High: Gr. 0(BL) to 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Blood Gluc,Fast(mmol/L), High: Gr. 1 (BL) to 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Blood Gluc,Fast(mmol/L), High: Missing(BL) to Gr 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Blood Gluc.,Fast.(mmol/L), High: Missing (All)	3 Participants	0 Participants	3 Participants	4 Participants	1 Participants	3 Participants	4 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Blood Gluc,Fast(mmol/L), Low: Gr. 0 (BL) to 0	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Blood Gluc,Fast(mmol/L), Low: Missing(BL) to Gr 0	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Blood Gluc.,Fast.(mmol/L), Low: Missing (All)	3 Participants	0 Participants	3 Participants	4 Participants	1 Participants	3 Participants	4 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Calcium (mmol/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	3 Participants	3 Participants	2 Participants	4 Participants	5 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Calcium (mmol/L), High: Gr. 1 (BL) to 0	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Calcium (mmol/L), Low: Gr. 0 (BL) to 0	2 Participants	2 Participants	2 Participants	3 Participants	2 Participants	3 Participants	4 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Calcium (mmol/L), Low: Gr. 0 (BL) to 1	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Calcium (mmol/L), Low: Gr. 0 (BL) to 2	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Calcium (mmol/L), Low: Gr. 1 (BL) to 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Creatinine (umol/L), High: Gr. 0 (BL) to 0	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	3 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Creatinine (umol/L), High: Gr. 0 (BL) to 1	1 Participants	2 Participants	2 Participants	2 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Creatinine (umol/L), High: Gr. 0 (BL) to 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Creatinine (umol/L), High: Gr. 1 (BL) to 0	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Creatinine (umol/L), High: Gr. 1 (BL) to 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Creatinine (umol/L), High: Gr. 1 (BL) to 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Glucose (mmol/L), High: Gr. 0 (BL) to 0	3 Participants	0 Participants	3 Participants	4 Participants	2 Participants	4 Participants	5 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Glucose (mmol/L), High: Missing (BL) to Gr. 0	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Glucose (mmol/L), High: Gr. 0 (BL) to 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Glucose (mmol/L), High: Missing (All)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Glucose (mmol/L), Low: Gr. 0 (BL) to 0	2 Participants	0 Participants	2 Participants	4 Participants	2 Participants	4 Participants	4 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Glucose (mmol/L), Low: Missing (BL) to Gr. 0	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Glucose (mmol/L), Low: Missing (All)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Phosphorus (mmol/L), Low: Missing (BL) to Gr. 0	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Phosphorus (mmol/L), Low: Missing (BL) to Gr. 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Phosphorus (mmol/L), Low: Missing (All)	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Potassium (mmol/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	2 Participants	4 Participants	2 Participants	4 Participants	5 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Potassium (mmol/L), High: Gr. 0 (BL) to 1	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Potassium (mmol/L), Low: Gr. 2 (BL) to 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline SGOT/AST (U/L), High: Gr. 0 (BL) to 0	2 Participants	2 Participants	2 Participants	4 Participants	2 Participants	4 Participants	5 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline SGOT/AST (U/L), High: Gr. 1 (BL) to 0	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline SGPT/ALT (U/L), High: Gr. 0 (BL) to 0	2 Participants	1 Participants	3 Participants	2 Participants	2 Participants	4 Participants	5 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline SGPT/ALT (U/L), High: Gr. 1 (BL) to 0	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline SGPT/ALT (U/L), High: Gr. 1 (BL) to 1	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Sodium (mmol/L), High: Gr. 1 (BL) to 0	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Sodium (mmol/L), Low: Gr. 0 (BL) to 0	3 Participants	2 Participants	2 Participants	4 Participants	2 Participants	4 Participants	3 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Sodium (mmol/L), Low: Gr. 0 (BL) to 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Sodium (mmol/L), Low: Gr. 1 (BL) to 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	3 Participants	2 Participants	1 Participants	3 Participants	4 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Triacylglyc. Lipase (U/L), High: Gr. 0 (BL) to 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Triacylglyc Lipase (U/L),High: Missing(BL) to Gr 2	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Uric Acid (umol/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	3 Participants	2 Participants	2 Participants	3 Participants	4 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Uric Acid (umol/L), High: Missing(BL) to Gr. 0	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Uric Acid (umol/L), High: Gr. 0 (BL) to 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Uric Acid (umol/L), High: Gr. 3 (BL) to 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Uric Acid (umol/L), High: Gr. 4 (BL) to 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Phosphorus (mmol/L), Low: Gr. 0 (BL) to 0	2 Participants	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Potassium (mmol/L), Low: Gr. 0 (BL) to 0	2 Participants	2 Participants	3 Participants	3 Participants	2 Participants	4 Participants	3 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Potassium (mmol/L), Low: Gr. 0 (BL) to 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Potassium (mmol/L), Low: Gr. 2 (BL) to 0	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Sodium (mmol/L), High: Gr. 0 (BL) to 0	3 Participants	2 Participants	3 Participants	3 Participants	2 Participants	4 Participants	4 Participants	1 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Sodium (mmol/L), High: Gr. 0 (BL) to 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Sodium (mmol/L), Low: Gr. 0 (BL) to 1	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline Glucose (mmol/L), Low: Gr. 0 (BL) to 1	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

Adverse Events

DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 participants at risk Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 participants at risk Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 participants at risk Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Ascites	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Diarrhoea	100.0% 1/1 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Cardiac disorders Acute myocardial infarction	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Gastroenteritis	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
General disorders Peripheral swelling	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Pneumonia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.

Other adverse events

Other adverse events
Measure	DLBCL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=1 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=3 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Non-Bridging: Idasanutlin 200 mg + Obinutuzumab 1000 mg n=2 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 200 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 150 mg + Rituximab 375 mg/m^2 n=3 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 150 mg orally in combination with rituximab 375 milligrams per square meter of body surface area (mg/m\^2) IV for 6 cycles (1 cycle = 28 days).	DLBCL Bridging: Idasanutlin 200 mg + Rituximab 375 mg/m^2 n=4 participants at risk Participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in this bridging cohort received induction treatment with idasanutlin 200 mg orally in combination with rituximab 375 mg/m\^2 IV for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 100 mg + Obinutuzumab 1000 mg n=2 participants at risk Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 100 milligrams (mg) orally in combination with a fixed dose of obinutuzumab 1000 mg intravenously (IV) for 6 cycles (1 cycle = 28 days).	FL Non-Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=4 participants at risk Participants with relapsed/refractory follicular lymphoma (FL) in this non-bridging dose-escalation cohort received induction treatment with idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for 6 cycles (1 cycle = 28 days).	FL Bridging: Idasanutlin 150 mg + Obinutuzumab 1000 mg n=5 participants at risk Participants with relapsed/refractory follicular lymphoma (FL) in this bridging cohort received induction treatment with single-agent obinutuzumab 1000 mg IV for Cycle 1 and then idasanutlin 150 mg orally in combination with a fixed dose of obinutuzumab 1000 mg IV for Cycles 2-6 (1 cycle = 28 days).
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	100.0% 2/2 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	75.0% 3/4 • Number of events 3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	40.0% 2/5 • Number of events 3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Blood and lymphatic system disorders Leukopenia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	66.7% 2/3 • Number of events 3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Blood and lymphatic system disorders Neutropenia	100.0% 1/1 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	100.0% 2/2 • Number of events 3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	100.0% 4/4 • Number of events 4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	75.0% 3/4 • Number of events 10 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	60.0% 3/5 • Number of events 4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 1/1 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	66.7% 2/3 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	100.0% 2/2 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 2/4 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	100.0% 2/2 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	100.0% 4/4 • Number of events 7 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	80.0% 4/5 • Number of events 6 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	66.7% 2/3 • Number of events 3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	75.0% 3/4 • Number of events 8 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	60.0% 3/5 • Number of events 5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	66.7% 2/3 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	100.0% 2/2 • Number of events 6 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	75.0% 3/4 • Number of events 8 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	100.0% 5/5 • Number of events 11 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Constipation	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	40.0% 2/5 • Number of events 3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 2/4 • Number of events 3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Musculoskeletal and connective tissue disorders Muscle spasms	100.0% 1/1 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	100.0% 1/1 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Clostridium difficile infection	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Herpes zoster	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Skin infection	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Anal inflammation	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Flatulence	100.0% 1/1 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Gastrointestinal disorders Vomiting	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	60.0% 3/5 • Number of events 4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Cardiac disorders Tachycardia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
General disorders Chest pain	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	75.0% 3/4 • Number of events 8 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
General disorders Oedema	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
General disorders Oedema peripheral	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
General disorders Pain	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
General disorders Pyrexia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 2/4 • Number of events 3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Chronic sinusitis	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Nasopharyngitis	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 2/4 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Infections and infestations Sinusitis	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Investigations Blood albumin decreased	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Investigations Blood bilirubin increased	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Investigations Blood lactate dehydrogenase increased	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Investigations Haemophilus test positive	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Investigations Lipase increased	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Musculoskeletal and connective tissue disorders Pain in extremity	100.0% 1/1 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Nervous system disorders Dizziness	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	66.7% 2/3 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Nervous system disorders Dysgeusia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Nervous system disorders Headache	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Nervous system disorders Memory impairment	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Nervous system disorders Taste disorder	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Nervous system disorders Trigeminal neuralgia	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Psychiatric disorders Depression	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	40.0% 2/5 • Number of events 2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	50.0% 1/2 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Vascular disorders Deep vein thrombosis	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Vascular disorders Hot flush	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	33.3% 1/3 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/5 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.
Vascular disorders Hypotension	0.00% 0/1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/3 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	25.0% 1/4 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/2 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	0.00% 0/4 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.	20.0% 1/5 • Number of events 1 • From first dose until 90 days after the last dose of study drug treatment (up to 31 months), except for serious AEs related to treatment Investigators seek information on adverse events (AEs) at each patient contact. All AEs were recorded, regardless of who reported them. After informed consent but prior to initiation of study drug, only serious AEs caused by protocol-mandated intervention were to be reported. After initiation of study drug, all AEs were to be reported until 90 days after the last dose of study drug. After this period, only serious AEs believed to be related to prior study drug treatment were to be reported.

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