Trial Outcomes & Findings for A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease (NCT NCT01680991)

NCT ID: NCT01680991

Last Updated: 2016-04-25

Results Overview

DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 48 participants
• Primary outcome timeframe: Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8
• Results posted on: 2016-04-25

Participant Flow

Participant milestones

Measure	CLL: 1000 mg Obinutuzumab Participants with chronic lymphocytic leukemia (CLL) received 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab Participants with diffuse large B-cell lymphoma (DLBCL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with follicular lymphoma (FL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Study STARTED	12	23	13
Overall Study COMPLETED	4	4	9
Overall Study NOT COMPLETED	8	19	4

Reasons for withdrawal

Measure	CLL: 1000 mg Obinutuzumab Participants with chronic lymphocytic leukemia (CLL) received 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab Participants with diffuse large B-cell lymphoma (DLBCL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with follicular lymphoma (FL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Overall Study Adverse Event	1	0	0
Overall Study Death	1	0	1
Overall Study Protocol Violation	0	1	0
Overall Study Withdrawal by Subject	5	1	0
Overall Study Progressive disease (PD)	0	10	0
Overall Study Physician Decision	0	7	2
Overall Study Bad physical condition	0	0	1
Overall Study PD confirmed in other hospital	1	0	0

Baseline Characteristics

A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease

Baseline characteristics by cohort

Measure	CLL: 1000 mg Obinutuzumab n=12 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=23 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=13 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	Total n=48 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 12.0 • n=5 Participants	53.3 years STANDARD_DEVIATION 15.8 • n=7 Participants	55.1 years STANDARD_DEVIATION 8.8 • n=5 Participants	55.6 years STANDARD_DEVIATION 13.4 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants

PRIMARY outcome

Timeframe: Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8

Population: PK analysis population included all participants who received at least 1 dose of study drug and had serum concentrations available. Here, number of participants analyzed = participants who were evaluable for this outcome.

DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=11 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=21 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=13 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1	1458 day*micrograms per milliliter Geometric Coefficient of Variation 34.8	1750 day*micrograms per milliliter Geometric Coefficient of Variation 20.5	1647 day*micrograms per milliliter Geometric Coefficient of Variation 20.7

PRIMARY outcome

Timeframe: Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8

Population: PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=11 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=21 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=13 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1	369 micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 31.8	442 micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 21.1	437 micrograms per milliliter (mcg/mL) Geometric Coefficient of Variation 16.7

PRIMARY outcome

Timeframe: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1

Population: PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=9 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=8 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=11 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8	12289 day*mcg/mL Geometric Coefficient of Variation 42.7	13000 day*mcg/mL Geometric Coefficient of Variation 37.3	11285 day*mcg/mL Geometric Coefficient of Variation 26.7

PRIMARY outcome

Timeframe: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1

Population: PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=9 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=8 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=11 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Cmax of Obinutuzumab at Cycle 8	1050 mcg/mL Geometric Coefficient of Variation 32.6	966 mcg/mL Geometric Coefficient of Variation 28.3	867 mcg/mL Geometric Coefficient of Variation 19.6

SECONDARY outcome

Timeframe: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1

Population: PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=9 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=8 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=11 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8	3.5 hours Interval 3.3 to 25.5	7.25 hours Interval 3.3 to 27.5	4.0 hours Interval 3.2 to 7.8

SECONDARY outcome

Timeframe: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing

Population: PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=9 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=6 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=11 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Apparent Terminal Half-life (t1/2)	21.5 day Geometric Coefficient of Variation 71.8	33.3 day Geometric Coefficient of Variation 68.6	26.7 day Geometric Coefficient of Variation 49.6

SECONDARY outcome

Timeframe: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1

Population: PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=9 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=6 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=11 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8	3.32 Liter Geometric Coefficient of Variation 27.9	4.49 Liter Geometric Coefficient of Variation 38.2	4.03 Liter Geometric Coefficient of Variation 21.5

SECONDARY outcome

Timeframe: Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1

Population: PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=9 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=8 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=11 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8	81.4 mL/day Geometric Coefficient of Variation 42.7	76.9 mL/day Geometric Coefficient of Variation 37.3	88.6 mL/day Geometric Coefficient of Variation 26.7

SECONDARY outcome

Timeframe: Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1

Population: PK population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" is the number of participants evaluable at the specified time point.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=11 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=22 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=13 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Minimum Observed Serum Concentration of Obinutuzumab Cycle 1-Day 8 (n=11,22,13)	156 mcg/mL Geometric Coefficient of Variation 57.2	186 mcg/mL Geometric Coefficient of Variation 25.2	148 mcg/mL Geometric Coefficient of Variation 39.2
Minimum Observed Serum Concentration of Obinutuzumab Cycle 1-Day 15 (n=11,22,13)	282 mcg/mL Geometric Coefficient of Variation 69.4	350 mcg/mL Geometric Coefficient of Variation 23.7	284 mcg/mL Geometric Coefficient of Variation 26.5
Minimum Observed Serum Concentration of Obinutuzumab Cycle 2 (n=11,21,13)	389 mcg/mL Geometric Coefficient of Variation 71.2	458 mcg/mL Geometric Coefficient of Variation 26.3	433 mcg/mL Geometric Coefficient of Variation 31.2
Minimum Observed Serum Concentration of Obinutuzumab Cycle 3 (n=10,18,13)	260 mcg/mL Geometric Coefficient of Variation 246	367 mcg/mL Geometric Coefficient of Variation 49.6	346 mcg/mL Geometric Coefficient of Variation 31
Minimum Observed Serum Concentration of Obinutuzumab Cycle 4 (n=10,14,13)	232 mcg/mL Geometric Coefficient of Variation 279.7	370 mcg/mL Geometric Coefficient of Variation 49.2	346 mcg/mL Geometric Coefficient of Variation 31
Minimum Observed Serum Concentration of Obinutuzumab Cycle 5 (n=9,11,11)	299 mcg/mL Geometric Coefficient of Variation 91.2	412 mcg/mL Geometric Coefficient of Variation 42	396 mcg/mL Geometric Coefficient of Variation 44.8
Minimum Observed Serum Concentration of Obinutuzumab Cycle 6 (n=9,10,11)	317 mcg/mL Geometric Coefficient of Variation 93.5	425 mcg/mL Geometric Coefficient of Variation 38.2	361 mcg/mL Geometric Coefficient of Variation 40.6
Minimum Observed Serum Concentration of Obinutuzumab Cycle 7 (n=9,10,11)	358 mcg/mL Geometric Coefficient of Variation 80.6	367 mcg/mL Geometric Coefficient of Variation 40.3	375 mcg/mL Geometric Coefficient of Variation 41.3
Minimum Observed Serum Concentration of Obinutuzumab Cycle 8 (n=9,8,11)	403 mcg/mL Geometric Coefficient of Variation 85.3	455 mcg/mL Geometric Coefficient of Variation 45.4	352 mcg/mL Geometric Coefficient of Variation 38.4

SECONDARY outcome

Timeframe: 1 month after the last dose (received on Day 148) of study drug

Population: Safety analysis population. Data reported only for DLBCL and FL arm groups.

CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (>) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=23 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=13 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria CR	0 percentage of participants Interval 0.0 to 14.82	0 percentage of participants Interval 0.0 to 24.71	—
Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria CRu	4.3 percentage of participants Interval 0.11 to 21.95	0 percentage of participants Interval 0.0 to 24.71	—

SECONDARY outcome

Timeframe: 1 month after the last dose (received on Day 148) of study drug

Population: Safety analysis population. Data reported only for DLBCL and FL arm groups.

PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=23 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=13 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria PR	8.7 percentage of participants Interval 1.07 to 28.04	46.2 percentage of participants Interval 19.22 to 74.87	—
Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria SD	8.7 percentage of participants Interval 1.07 to 28.04	30.8 percentage of participants Interval 9.09 to 61.43	—
Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria PD	65.2 percentage of participants Interval 42.73 to 83.62	23.1 percentage of participants Interval 5.04 to 53.81	—

SECONDARY outcome

Timeframe: From screening to up to 1 month after the last dose (received on Day 148) of study drug

Population: Safety analysis population. Data reported only for DLBCL and FL arm groups.

CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN >1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=23 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=13 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria CR	0 percentage of participants Interval 0.0 to 14.82	0 percentage of participants Interval 0.0 to 24.71	—
Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria CRu	4.3 percentage of participants Interval 0.11 to 21.95	0 percentage of participants Interval 0.0 to 24.71	—

SECONDARY outcome

Timeframe: From screening to up to 1 month after the last dose (received on Day 148) of study drug

Population: Safety analysis population. Data reported only for DLBCL and FL arm groups.

PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=23 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=13 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria PR	21.7 percentage of participants Interval 7.46 to 43.7	61.5 percentage of participants Interval 31.58 to 86.14	—
Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria SD	26.1 percentage of participants Interval 10.23 to 48.41	30.8 percentage of participants Interval 9.09 to 61.43	—
Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria PD	39.1 percentage of participants Interval 19.71 to 61.46	7.7 percentage of participants Interval 0.19 to 36.03	—

SECONDARY outcome

Timeframe: 2 months after the last dose (received on Day 148) of study drug

Population: Safety analysis population. Data reported only for CLL participants.

CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (<) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] >1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) >100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) >11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=12 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines CRe	0 percentage of participants Interval 0.0 to 26.46	—	—
Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines CRi	0 percentage of participants Interval 0.0 to 26.46	—	—

SECONDARY outcome

Timeframe: 2 months after the last dose (received on Day 148) of study drug

Population: Safety analysis population. Data reported only for CLL participants

Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=12 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines PR	58.3 percentage of participants Interval 27.67 to 84.83	—	—
Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines SD	8.3 percentage of participants Interval 0.21 to 38.48	—	—
Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines PD	16.7 percentage of participants Interval 2.09 to 48.41	—	—

SECONDARY outcome

Timeframe: From screening to up to 2 months after the last dose (received on Day 148) of study drug

Population: Safety analysis population. Data reported only for CLL participants.

CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL <4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu >1.5 x 10^9/L without the need for EGF, ii. Plt >100 x 10^9/L without the need for EGF, and iii. Hb >11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=12 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines CRe	0 percentage of participants Interval 0.0 to 26.46	—	—
Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines CRi	0 percentage of participants Interval 0.0 to 26.46	—	—

SECONDARY outcome

Timeframe: From screening to up to 2 months after the last dose (received on Day 148) of study drug

Population: Safety analysis population. Data reported only for CLL participants.

Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=12 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines PR	75.0 percentage of participants Interval 42.81 to 94.51	—	—
Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines SD	8.3 percentage of participants Interval 0.21 to 38.48	—	—
Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines PD	0 percentage of participants Interval 0.0 to 26.46	—	—

SECONDARY outcome

Timeframe: Cycle 1 (Day 1), Cycle 4 (Day 1), 4-week follow-up, 3 and 6 month follow-up

Population: Safety analysis population. "n" represents the number of participants who were evaluable at the specified time point.

For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=12 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=23 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=13 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Number of Participants With Positive Human Anti-Human Antibodies (HAHA) Cycle 1, Day 1 (n=12,23,13)	0 participants	0 participants	0 participants
Number of Participants With Positive Human Anti-Human Antibodies (HAHA) Cycle 4, Day 1 (n=11,14,13)	0 participants	0 participants	0 participants
Number of Participants With Positive Human Anti-Human Antibodies (HAHA) 4 week follow-up (n=10,10,11)	0 participants	0 participants	0 participants
Number of Participants With Positive Human Anti-Human Antibodies (HAHA) 3 month follow-up (n=8,4,11)	0 participants	0 participants	0 participants
Number of Participants With Positive Human Anti-Human Antibodies (HAHA) 6 month follow-up (n=7,4,11)	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Cycle 1, Day 1

Population: Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=10 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=20 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=7 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)	2 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year

Population: Safety analysis population.

Depletion is defined as cluster of differentiation (CD) 19+ B-cell count <0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=12 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=23 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=13 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Number of Participants With B-cell Depletion or Recovery B-cell Depletion	9 participants	23 participants	13 participants
Number of Participants With B-cell Depletion or Recovery B-cell Recovery	4 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year

Population: Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

Depletion is defined as CD19+ B-cell count < 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=9 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=23 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=12 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Duration of Depletion of CD19+ B-cell	238.7 days Standard Deviation 182.5	141.0 days Standard Deviation 167.5	386.0 days Standard Deviation 176.0

SECONDARY outcome

Timeframe: Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year

Population: Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" represents the number of participants evaluable for the specified category.

Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.

Outcome measures

Measure	CLL: 1000 mg Obinutuzumab n=4 Participants Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=1 Participants Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=1 Participants Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Time to Recovery of CD19+ B-cell Time to recovery with PD (n=1,0,1)	419 days Standard Deviation NA Standard deviation is not applicable as data of a single participant is reported.	NA days Standard Deviation NA No participant experienced B-cell recovery for this category.	331.0 days Standard Deviation NA Standard deviation is not applicable as data of a single participant is reported.
Time to Recovery of CD19+ B-cell Time to recovery without PD (n=3,1,0)	229.0 days Standard Deviation 87.5	515.0 days Standard Deviation NA Standard deviation is not applicable as data of a single participant is reported.	NA days Standard Deviation NA No participant experienced B-cell recovery for this category.

Adverse Events

CLL: 1000 mg Obinutuzumab

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

DLBCL: 1000 mg Obinutuzumab

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

FL: 1000 mg Obinutuzumab

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	CLL: 1000 mg Obinutuzumab n=12 participants at risk Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=23 participants at risk Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=13 participants at risk Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Infections and infestations Pneumonia	16.7% 2/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Infections and infestations Infected cyst	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Infections and infestations Urinary tract infection	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Blood and lymphatic system disorders Neutropenia	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Blood and lymphatic system disorders Thrombocytopenia	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
General disorders Submandibular mass	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations Platelet count decreased	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.

Other adverse events

Measure	CLL: 1000 mg Obinutuzumab n=12 participants at risk Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.	DLBCL: 1000 mg Obinutuzumab n=23 participants at risk Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.	FL: 1000 mg Obinutuzumab n=13 participants at risk Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
Injury, poisoning and procedural complications Infusion related reaction	58.3% 7/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	21.7% 5/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	23.1% 3/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Injury, poisoning and procedural complications Scratch	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
General disorders Pyrexia	50.0% 6/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	13.0% 3/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	15.4% 2/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
General disorders Chills	25.0% 3/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
General disorders Chest discomfort	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
General disorders Local swelling	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Infections and infestations Nasopharyngitis	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	8.7% 2/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Infections and infestations Epididymitis	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Infections and infestations Gingivitis	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Infections and infestations Herpes zoster	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Infections and infestations Influenza	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Infections and infestations Urinary tract infection	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Blood and lymphatic system disorders Anaemia	16.7% 2/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 2/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Blood and lymphatic system disorders Lymph node pain	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Blood and lymphatic system disorders Leukocytosis	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Blood and lymphatic system disorders Leukopenia	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Blood and lymphatic system disorders Neutropenia	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	8.7% 2/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Gastrointestinal disorders Nausea	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Gastrointestinal disorders Vomiting	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Gastrointestinal disorders Toothache	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations Alanine aminotransferase increased	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	13.0% 3/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations Aspartate aminotransferase increased	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	13.0% 3/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations Blood creatinine increased	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations Blood pressure decreased	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations Blood uric acid increased	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations Heart rate decreased	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations Neutrophil count decreased	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations Platelet count decreased	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Investigations White blood cell count decreased	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 4/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Musculoskeletal and connective tissue disorders Muscular weakness	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Vascular disorders Hypertension	16.7% 2/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Vascular disorders Deep vein thrombosis	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Nervous system disorders Tremor	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Nervous system disorders Extrapyramidal disorder	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	7.7% 1/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Psychiatric disorders Insomnia	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	4.3% 1/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Eye disorders Scleral haemorrhage	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.
Renal and urinary disorders Urinary retention	8.3% 1/12 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/23 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.	0.00% 0/13 • Until 3 months after last study drug (Up to approximately 9 months) Safety analysis population.

Additional Information

Medical Communications

Hoffmann-LaRoche

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