Trial Outcomes & Findings for A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma (NCT NCT02631577)

NCT ID: NCT02631577

Last Updated: 2022-04-13

Results Overview

Complete response (CR) was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the IRC.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: 6 months (up to clinical cut-off date (CCOD) of 23 October 2018)
• Results posted on: 2022-04-13

Participant Flow

The study was conducted at 14 sites in France (9) and USA (5).

All participants received daily low-dose aspirin (81-100 mg) during lenalidomide treatment and until 28 days after the last dose of lenalidomide. Participants who are unable to tolerate aspirin, who have a history of thromboembolism (TE), and who are at high risk of TE, received warfarin or low-molecular-weight heparin (LMWH).

Participant milestones

Measure	Atezolizumab-G-lena 15mg Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide	Atezolizumab-G-lena 20mg Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Overall Study STARTED	4	34
Overall Study COMPLETED	3	24
Overall Study NOT COMPLETED	1	10

Reasons for withdrawal

Measure	Atezolizumab-G-lena 15mg Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide	Atezolizumab-G-lena 20mg Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Overall Study Death	1	7
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

Baseline characteristics by cohort

Measure	Atezolizumab-G-lena 15mg n=4 Participants Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide	Atezolizumab-G-lena 20mg n=34 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.	Total n=38 Participants Total of all reporting groups
Age, Continuous	56.5 Years STANDARD_DEVIATION 9.1 • n=5 Participants	60.4 Years STANDARD_DEVIATION 9.7 • n=7 Participants	60.0 Years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	3 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Not Stated	0 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months (up to clinical cut-off date (CCOD) of 23 October 2018)

Population: As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.

Complete response (CR) was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the IRC.

Outcome measures

Measure	Atezolizumab-G-lena 15mg Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=32 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Percentage of Participants Achieving Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria	—	71.9 Percentage of Participants Interval 56.06 to 84.47

SECONDARY outcome

Timeframe: 6 months (up to CCOD of 23 October 2018)

Population: As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.

CR was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the Investigator.

Outcome measures

Measure	Atezolizumab-G-lena 15mg Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=32 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Modified Lugano 2014 Criteria	—	75 Percentage of Participants Interval 59.39 to 86.91

SECONDARY outcome

Timeframe: 6 months (up to CCOD of 23 October 2018)

Population: As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.

CR was evaluated through use of CT scans, using the Lugano 2014 criteria. Response was determined by the IRC and by the Investigator.

Outcome measures

Measure	Atezolizumab-G-lena 15mg Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=32 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Lugano 2014 Criteria Determined by the IRC with CT or MRI	—	31.3 Percentage of Participants Interval 18.04 to 47.21
Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Lugano 2014 Criteria Determined by Investigator with CT or MRI	—	50 Percentage of Participants Interval 34.41 to 65.59

SECONDARY outcome

Timeframe: 6 months (up to CCOD of 23 October 2018)

Population: As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.

Objective response was evaluated through use of PET-CT scans, using the Lugano 2014 or modified Lugano 2014 criteria. Response was determined by the IRC and by the Investigator.

Outcome measures

Measure	Atezolizumab-G-lena 15mg Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=32 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of PET-CT Scans Determined by IRC, based on Lugano 2014 - PET	—	81.3 Percentage of Participants Interval 66.31 to 91.5
Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of PET-CT Scans Determined by Inv., based on Lugano 2014 - PET	—	84.4 Percentage of Participants Interval 69.92 to 93.63
Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of PET-CT Scans Determined by IRC, Modified Lugano 2014 - PET-CT	—	78.1 Percentage of Participants Interval 62.81 to 89.26
Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of PET-CT Scans Determined by Inv, Modified Lugano 2014 - PET-CT	—	84.4 Percentage of Participants Interval 69.92 to 93.63

SECONDARY outcome

Timeframe: 6 months (up to CCOD of 23 October 2018)

Population: As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.

Objective response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the IRC and by the Investigator.

Outcome measures

Measure	Atezolizumab-G-lena 15mg Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=32 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of CT Scans Alone Determined by IRC, based on Lugano 2014 - CT	—	81.3 Percentage of Participants Interval 66.31 to 91.5
Percentage of Participants With Objective Response (CR or PR) at EOI as Determined by the IRC and Investigator on the Basis of CT Scans Alone Determined by Inv., based on Lugano 2014 - CT	—	87.5 Percentage of Participants Interval 73.64 to 95.62

SECONDARY outcome

Timeframe: 30 months

Population: As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.

Best Response was evaluated through use of CT scans alone, using the Lugano 2014. Response was determined by the Investigator.

Outcome measures

Measure	Atezolizumab-G-lena 15mg Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=32 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Percentage of Participants With Best Response (CR or PR) During the Study as Determined by the Investigator on the Basis of CT Scans Alone PR	—	18.8 Percentage Interval 8.5 to 33.69
Percentage of Participants With Best Response (CR or PR) During the Study as Determined by the Investigator on the Basis of CT Scans Alone Best Response (CR,PR)	—	87.5 Percentage Interval 73.64 to 95.62
Percentage of Participants With Best Response (CR or PR) During the Study as Determined by the Investigator on the Basis of CT Scans Alone CR	—	68.8 Percentage Interval 52.79 to 81.96

SECONDARY outcome

Timeframe: Baseline up to approximately 59 months

Population: The Safety Evaluable Population included participants who received at least one dose of any study treatment.

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Outcome measures

Measure	Atezolizumab-G-lena 15mg n=4 Participants Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=34 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Percentage of Participants With Adverse Events and Serious Adverse Events Adverse Events	4 Participants	34 Participants
Percentage of Participants With Adverse Events and Serious Adverse Events Serious Adverse Events	2 Participants	16 Participants

SECONDARY outcome

Timeframe: Day 1 - Day 28 of second cycle

Population: The Safety Evaluable Population included participants who received at least one dose of any study treatment.

Does limiting toxicity (DLT) is defined as any one of the following events occurring during Cycle 2 of treatment and assessed by the investigator as related to study treatment: - Adverse event of any grade that leads to a delay of more than 14 days at the start of the next treatment cycle; - Hematologic adverse events (neutropenia, thrombocytopenia); - Non-hematologic adverse event, except IRRs, diarrhea, nausea or vomiting

Outcome measures

Measure	Atezolizumab-G-lena 15mg n=4 Participants Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=34 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 2 of Study Treatment	0 Number of Participants	0 Number of Participants

SECONDARY outcome

Timeframe: Baseline up to approximately 59 months

Population: The Safety Evaluable Population included participants who received at least one dose of any study treatment.

The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year

Outcome measures

Measure	Atezolizumab-G-lena 15mg n=4 Participants Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=34 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Serum Concentration of Obinutuzumab (mcg/mL) Ind C1 D1 - Predose	—	0.634 mcg/mL Standard Deviation 0.857
Serum Concentration of Obinutuzumab (mcg/mL) Ind C1 D1 - 30 min. Postdose	364 mcg/mL Standard Deviation 45.9	375 mcg/mL Standard Deviation 163
Serum Concentration of Obinutuzumab (mcg/mL) Ind C2 D1 - Predose	288 mcg/mL Standard Deviation 84.2	392 mcg/mL Standard Deviation 164
Serum Concentration of Obinutuzumab (mcg/mL) Ind C2 D1 - 30 min. Postdose	606 mcg/mL Standard Deviation 62.4	753 mcg/mL Standard Deviation 225
Serum Concentration of Obinutuzumab (mcg/mL) Ind C4 D1 - Predose	175 mcg/mL Standard Deviation 38.5	301 mcg/mL Standard Deviation 150
Serum Concentration of Obinutuzumab (mcg/mL) Ind C4 D1 - 30 min. Postdose	509 mcg/mL Standard Deviation 47.0	657 mcg/mL Standard Deviation 198
Serum Concentration of Obinutuzumab (mcg/mL) Ind C6 D1 - Predose	230 mcg/mL Standard Deviation 12.3	272 mcg/mL Standard Deviation 106
Serum Concentration of Obinutuzumab (mcg/mL) Ind C6 D1 - 30 min. Postdose	503 mcg/mL Standard Deviation 25.5	652 mcg/mL Standard Deviation 177
Serum Concentration of Obinutuzumab (mcg/mL) Maint M1 - Predose	114 mcg/mL Standard Deviation 16.7	201 mcg/mL Standard Deviation 104
Serum Concentration of Obinutuzumab (mcg/mL) Maint M7 - Predose	66.1 mcg/mL Standard Deviation 20.4	112 mcg/mL Standard Deviation 52.1
Serum Concentration of Obinutuzumab (mcg/mL) Maint M13 - Predose	77.9 mcg/mL Standard Deviation NA The standard deviation couldn't be calculated from one participant.	104 mcg/mL Standard Deviation 62.9
Serum Concentration of Obinutuzumab (mcg/mL) Maint M19 - Predose	94.0 mcg/mL Standard Deviation 24.0	111 mcg/mL Standard Deviation 49.8
Serum Concentration of Obinutuzumab (mcg/mL) TRTC	—	148 mcg/mL Standard Deviation 103
Serum Concentration of Obinutuzumab (mcg/mL) OD120FU	23.3 mcg/mL Standard Deviation NA The standard deviation couldn't be calculated from one participant.	46.2 mcg/mL Standard Deviation 38.6
Serum Concentration of Obinutuzumab (mcg/mL) O1YFU	46.9 mcg/mL Standard Deviation 66.2	57.9 mcg/mL Standard Deviation 115

SECONDARY outcome

Timeframe: Baseline up to approximately 59 months

Population: The Safety Evaluable Population included participants who received at least one dose of any study treatment.

The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year

Outcome measures

Measure	Atezolizumab-G-lena 15mg n=4 Participants Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=34 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Serum Concentration of Atezolizumab (mcg/mL) Ind C2 D1 - Predose	—	0.184 micrograms per milliliter (mcg/mL) Standard Deviation NA The standard deviation couldn't be calculated from one participant.
Serum Concentration of Atezolizumab (mcg/mL) Ind C2 D1 - 30 min. Postdose	345 micrograms per milliliter (mcg/mL) Standard Deviation 195	279 micrograms per milliliter (mcg/mL) Standard Deviation 123
Serum Concentration of Atezolizumab (mcg/mL) Ind C2 D15 - Predose	73.8 micrograms per milliliter (mcg/mL) Standard Deviation 6.47	90.0 micrograms per milliliter (mcg/mL) Standard Deviation 33.8
Serum Concentration of Atezolizumab (mcg/mL) Ind C4 D1 - Predose	128 micrograms per milliliter (mcg/mL) Standard Deviation 33.9	226 micrograms per milliliter (mcg/mL) Standard Deviation 93.9
Serum Concentration of Atezolizumab (mcg/mL) Ind C4 D1 - 30 min. Postdose	340 micrograms per milliliter (mcg/mL) Standard Deviation 38.2	477 micrograms per milliliter (mcg/mL) Standard Deviation 126
Serum Concentration of Atezolizumab (mcg/mL) Ind C6 D1 - Predose	194 micrograms per milliliter (mcg/mL) Standard Deviation 40.6	279 micrograms per milliliter (mcg/mL) Standard Deviation 117
Serum Concentration of Atezolizumab (mcg/mL) Maint M1 - Predose	79.0 micrograms per milliliter (mcg/mL) Standard Deviation 67.6	172 micrograms per milliliter (mcg/mL) Standard Deviation 76.5
Serum Concentration of Atezolizumab (mcg/mL) Maint M1 - Day 2, 30 min. Postdose	653 micrograms per milliliter (mcg/mL) Standard Deviation 106	666 micrograms per milliliter (mcg/mL) Standard Deviation 185
Serum Concentration of Atezolizumab (mcg/mL) Maint M4 - Predose	174 micrograms per milliliter (mcg/mL) Standard Deviation 32.9	292 micrograms per milliliter (mcg/mL) Standard Deviation 97.1
Serum Concentration of Atezolizumab (mcg/mL) Maint M7 - Predose	209 micrograms per milliliter (mcg/mL) Standard Deviation 12.7	322 micrograms per milliliter (mcg/mL) Standard Deviation 109
Serum Concentration of Atezolizumab (mcg/mL) Maint M13 - Predose	203 micrograms per milliliter (mcg/mL) Standard Deviation NA The standard deviation couldn't be calculated from one participant.	309 micrograms per milliliter (mcg/mL) Standard Deviation 140
Serum Concentration of Atezolizumab (mcg/mL) Maint M19 - Predose	351 micrograms per milliliter (mcg/mL) Standard Deviation NA The standard deviation couldn't be calculated from one participant.	327 micrograms per milliliter (mcg/mL) Standard Deviation 140
Serum Concentration of Atezolizumab (mcg/mL) TRTC	—	116 micrograms per milliliter (mcg/mL) Standard Deviation 81.9
Serum Concentration of Atezolizumab (mcg/mL) PK FU 120D	46.0 micrograms per milliliter (mcg/mL) Standard Deviation NA The standard deviation couldn't be calculated from one participant.	38.4 micrograms per milliliter (mcg/mL) Standard Deviation 24.6

SECONDARY outcome

Timeframe: Baseline up to approximately 59 months

Population: The Safety Evaluable Population included participants who received at least one dose of any study treatment.

The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; HR = Hour

Outcome measures

Measure	Atezolizumab-G-lena 15mg n=4 Participants Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=34 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Serum Concentration of Lenalidomide (ng/mL) Ind C1 D15 - Predose	12.6 nanograms/milliliter (ng/mL) Standard Deviation 14.3	13.0 nanograms/milliliter (ng/mL) Standard Deviation 11.4
Serum Concentration of Lenalidomide (ng/mL) Ind C1 D15 - 2.0 hr. Postdose	254 nanograms/milliliter (ng/mL) Standard Deviation 115	294 nanograms/milliliter (ng/mL) Standard Deviation 114
Serum Concentration of Lenalidomide (ng/mL) Ind C2 D15 - Predose	3.57 nanograms/milliliter (ng/mL) Standard Deviation 3.25	15.0 nanograms/milliliter (ng/mL) Standard Deviation 13.0
Serum Concentration of Lenalidomide (ng/mL) Ind C2 D15 - 30 min. Postdose	241 nanograms/milliliter (ng/mL) Standard Deviation 116	293 nanograms/milliliter (ng/mL) Standard Deviation 233
Serum Concentration of Lenalidomide (ng/mL) Ind C2 D15 -1.0 hr. Postdose	224 nanograms/milliliter (ng/mL) Standard Deviation 43.1	354 nanograms/milliliter (ng/mL) Standard Deviation 120
Serum Concentration of Lenalidomide (ng/mL) Ind C2 D15 - 2.0 hr. Postdose	146 nanograms/milliliter (ng/mL) Standard Deviation 41.9	262 nanograms/milliliter (ng/mL) Standard Deviation 82.1
Serum Concentration of Lenalidomide (ng/mL) Ind C2 D15 - 4.0 hr. Postdose	95.8 nanograms/milliliter (ng/mL) Standard Deviation 18.3	150 nanograms/milliliter (ng/mL) Standard Deviation 47.1
Serum Concentration of Lenalidomide (ng/mL) Ind C2 D15 - 8.0 hr. Postdose	45.9 nanograms/milliliter (ng/mL) Standard Deviation 23.9	68.4 nanograms/milliliter (ng/mL) Standard Deviation 33.6
Serum Concentration of Lenalidomide (ng/mL) Ind C6 D15 - Predose	5.72 nanograms/milliliter (ng/mL) Standard Deviation 3.73	9.17 nanograms/milliliter (ng/mL) Standard Deviation 6.87
Serum Concentration of Lenalidomide (ng/mL) Ind C6 D15 - 2.0 hr. Postdose	200 nanograms/milliliter (ng/mL) Standard Deviation 57.5	214 nanograms/milliliter (ng/mL) Standard Deviation 77.6

SECONDARY outcome

Timeframe: Baseline up to approximately 59 months

Population: The Safety Evaluable Population included participants who received at least one dose of any study treatment.

The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples from participants were negative for HAHAs to obinutuzumab and the results are shown below.

Outcome measures

Measure	Atezolizumab-G-lena 15mg n=4 Participants Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=34 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab Baseline - Negative	4 Participants	34 Participants
Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab Ind C6 D1 - Negative	3 Participants	27 Participants
Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab Study drug completion or early discontinuation - Negative	0 Participants	15 Participants
Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab OB, PK, IMMUNO FU 120D - Negative	1 Participants	11 Participants
Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab OB, PK, IMMUNO FU 1YR - Negative	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline up to approximately 59 months

Population: The Safety Evaluable Population included participants who received at least one dose of any study treatment.

The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year. All baseline and post-baseline samples were negative for ATAs to atezolizumab and the results are shown below.

Outcome measures

Measure	Atezolizumab-G-lena 15mg n=4 Participants Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide.	Atezolizumab-G-lena 20mg n=34 Participants Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Ind C2 D1 - Negative	4 Participants	31 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Ind C2 D15 - Negative	2 Participants	32 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Ind C4 D1 - Negative	3 Participants	29 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Ind C6 D1 - Negative	3 Participants	28 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Maint M1 - Negative	3 Participants	27 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Maint M4 - Negative	3 Participants	25 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Maint M7 - Negative	2 Participants	21 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Maint M13 - Negative	1 Participants	20 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Maint M19 - Negative	2 Participants	12 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab Study drug completion or early discontinuation - Negative	2 Participants	15 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab ATEZO, PK, IMMUNO FU 120D - Negative	1 Participants	11 Participants
Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab ATEZO, PK, IMMUNO FU 1YR - Negative	2 Participants	3 Participants

Adverse Events

Atezolizumab-G-lena 15mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Atezolizumab-G-lena 20mg

Serious events: 16 serious events

Other events: 34 other events

Deaths: 7 deaths

Serious adverse events

Measure	Atezolizumab-G-lena 15mg n=4 participants at risk Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide	Atezolizumab-G-lena 20mg n=34 participants at risk Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders ABDOMINAL PAIN	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders ADMINISTRATION SITE EXTRAVASATION	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations EAR INFECTION	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations EPIDIDYMITIS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations INFLUENZA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations PNEUMONIA PARAINFLUENZAE VIRAL	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Metabolism and nutrition disorders DEHYDRATION	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MENINGIOMA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR FLARE	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Vascular disorders ORTHOSTATIC HYPOTENSION	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations CELLULITIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations PNEUMONIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ATYPICAL FIBROXANTHOMA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA OF THE SKIN	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SARCOMATOID CARCINOMA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.

Other adverse events

Measure	Atezolizumab-G-lena 15mg n=4 participants at risk Participants were administered obinutuzumab, atezolizumab, and 15 mg of lenalidomide	Atezolizumab-G-lena 20mg n=34 participants at risk Participants were administered obinutuzumab, atezolizumab, and 20 mg of lenalidomide.
Blood and lymphatic system disorders ANAEMIA	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	17.6% 6/34 • Number of events 6 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Blood and lymphatic system disorders NEUTROPENIA	75.0% 3/4 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	41.2% 14/34 • Number of events 43 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Blood and lymphatic system disorders THROMBOCYTOPENIA	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	26.5% 9/34 • Number of events 14 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Cardiac disorders TACHYCARDIA	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Ear and labyrinth disorders VERTIGO	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Endocrine disorders HYPERTHYROIDISM	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	20.6% 7/34 • Number of events 9 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	17.6% 6/34 • Number of events 6 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Eye disorders LACRIMATION INCREASED	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders ABDOMINAL PAIN	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	23.5% 8/34 • Number of events 10 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	50.0% 2/4 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders CONSTIPATION	75.0% 3/4 • Number of events 5 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	35.3% 12/34 • Number of events 13 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders DIARRHOEA	75.0% 3/4 • Number of events 9 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	55.9% 19/34 • Number of events 42 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 6 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders NAUSEA	100.0% 4/4 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	11.8% 4/34 • Number of events 7 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders RECTAL HAEMORRHAGE	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders STOMATITIS	50.0% 2/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders VOMITING	100.0% 4/4 • Number of events 8 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders ASTHENIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	41.2% 14/34 • Number of events 20 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders AXILLARY PAIN	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders FATIGUE	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	23.5% 8/34 • Number of events 10 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders INFLUENZA LIKE ILLNESS	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders NON-CARDIAC CHEST PAIN	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders OEDEMA PERIPHERAL	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	14.7% 5/34 • Number of events 8 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders PERIPHERAL SWELLING	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders PYREXIA	75.0% 3/4 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	14.7% 5/34 • Number of events 6 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders XEROSIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Hepatobiliary disorders CHOLECYSTITIS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Hepatobiliary disorders HEPATOCELLULAR INJURY	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations BRONCHIOLITIS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations BRONCHITIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	29.4% 10/34 • Number of events 13 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations CONJUNCTIVITIS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations FUNGAL SKIN INFECTION	50.0% 2/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations GASTROENTERITIS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations HERPES ZOSTER	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations INFLUENZA	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	17.6% 6/34 • Number of events 6 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations NASOPHARYNGITIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	17.6% 6/34 • Number of events 10 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations PHARYNGITIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations RHINITIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	26.5% 9/34 • Number of events 12 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations SINUSITIS	100.0% 4/4 • Number of events 5 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	20.6% 7/34 • Number of events 13 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations TINEA INFECTION	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	14.7% 5/34 • Number of events 8 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Injury, poisoning and procedural complications FALL	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	32.4% 11/34 • Number of events 12 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Injury, poisoning and procedural complications SKIN ABRASION	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Investigations ALANINE AMINOTRANSFERASE INCREASED	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Investigations AMYLASE INCREASED	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Investigations LIPASE INCREASED	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	11.8% 4/34 • Number of events 6 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Investigations WEIGHT DECREASED	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Metabolism and nutrition disorders FLUID OVERLOAD	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Metabolism and nutrition disorders HYPERGLYCAEMIA	50.0% 2/4 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Metabolism and nutrition disorders HYPOKALAEMIA	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders ARTHRALGIA	50.0% 2/4 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	20.6% 7/34 • Number of events 10 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders BACK PAIN	25.0% 1/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders FLANK PAIN	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders GROIN PAIN	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	23.5% 8/34 • Number of events 15 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	14.7% 5/34 • Number of events 9 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	14.7% 5/34 • Number of events 5 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Nervous system disorders DIZZINESS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Nervous system disorders NEUROPATHY PERIPHERAL	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Nervous system disorders PARAESTHESIA	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	11.8% 4/34 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Nervous system disorders POST HERPETIC NEURALGIA	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Nervous system disorders TREMOR	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Psychiatric disorders DEPRESSION	50.0% 2/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Psychiatric disorders INSOMNIA	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	11.8% 4/34 • Number of events 5 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Renal and urinary disorders HYDRONEPHROSIS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Renal and urinary disorders URINARY RETENTION	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders COUGH	50.0% 2/4 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	35.3% 12/34 • Number of events 14 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	14.7% 5/34 • Number of events 5 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	50.0% 2/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	11.8% 4/34 • Number of events 5 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	2.9% 1/34 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Skin and subcutaneous tissue disorders NIGHT SWEATS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	11.8% 4/34 • Number of events 4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Skin and subcutaneous tissue disorders PRURITUS	50.0% 2/4 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	14.7% 5/34 • Number of events 6 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Skin and subcutaneous tissue disorders RASH	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	20.6% 7/34 • Number of events 8 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 6 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Vascular disorders DEEP VEIN THROMBOSIS	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	0.00% 0/34 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Vascular disorders HYPERTENSION	25.0% 1/4 • Number of events 1 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Eye disorders DRY EYE	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	11.8% 4/34 • Number of events 6 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
General disorders MALAISE	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Immune system disorders HYPOGAMMAGLOBULINAEMIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations ACUTE SINUSITIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations CYSTITIS	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Infections and infestations PNEUMONIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	14.7% 5/34 • Number of events 5 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Renal and urinary disorders DYSURIA	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	8.8% 3/34 • Number of events 3 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.
Vascular disorders HOT FLUSH	0.00% 0/4 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.	5.9% 2/34 • Number of events 2 • Baseline up to approximately 59 months The safety population included all participants who received at least one treatment with study medication. The adverse event severity grading scale for the NCI CTCAE v4.0 was used.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

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