A Study of Atezolizumab in Combination With Carboplatin P... | NCT02366143

ID	Type	Description	Link
2014-003207-30	EudraCT Number

Label	Type	Description	Intervention Names
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Experimental	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.	Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Drug: Carboplatin Drug: Paclitaxel
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Experimental	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.	Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Active Comparator	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Name	Type	Description	Arm Group Labels	Other Names
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody	Drug	Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.

Measure	Description	Time Frame
Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population	Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.	Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)
Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population	Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population	Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)
Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population	Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population	Baseline until death (up approximately 53 months)

Measure	Description	Time Frame
PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population	PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.	Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Ironwood Cancer & Research Centers		Chandler	Arizona	85224	United States
Arizona Oncology Associates

PubMed Identifier	Type	Citation	Retractions
40379995	Derived	Zhou C, Dong X, Chen G, Wang Z, Wu X, Yao Y, Zhang Y, Cheng Y, Pan H, Zhang X, Cui J, Wang L, Chen X, Li X, Wang Z, Wang Q, He J, Wang M, Yan I, Qian L, Xu M, Huang X, Sun C, Cai J, Wu Q, Ballinger M, Kaul M, Srivastava MK. Atezolizumab plus bevacizumab and chemotherapy in metastatic nonsquamous NSCLC: the randomized double-blind phase 3 IMpower151 trial. Nat Med. 2025 Jul;31(7):2375-2384. doi: 10.1038/s41591-025-03658-y. Epub 2025 May 16.
37545290

ID	Title	Description
FG000	Arm C	Bevacizumab+Paclitaxel+Carboplatin
FG001	Arm B	Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 11, 2020	Aug 21, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population

Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.

Teff-high WT population is defined as the Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000356 OG001336

Title

Denominators

Categories

Teff-high WT Population

- ParticipantsOG000155
- ParticipantsOG001129

Title	Measurements
	OG00011.3(9.1 to 13.0)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	ITT-WT population	Log Rank		<0.0001		Hazard Ratio (HR)	0.62			2-Sided	95	0.52	0.74					Superiority	Stratified Analysis
OG000 OG001	Teff-high WT Population

Primary

Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population

ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Posted

Median

95% Confidence Interval

Months

Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Primary

Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population

ITT-WT population is defined as the ITT population excluding patients with an activating EGFR mutation or ALK translocation.

Posted

Median

95% Confidence Interval

Months

Baseline until death (up approximately 53 months)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population

PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population

PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.

Teff-high population is defined as the patients in the ITT population with Teff signature expression >=-1.91. ITT population is defined as all randomized patients, regardless of receipt of the assigned treatment.

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population

PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Secondary

PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup

PFS as Determined by the Investigator according to RECIST v1.1, in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)

The PD-L1-selected WT populations are defined as the PD-L1-selected populations (TC2/3 or IC2/3 population or TC1/2/3 or IC1/2/3 population) excluding patients with a sensitizing EGFR mutation or ALK translocation.

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

OS in Arm B Versus Arm C by PD-L1 Subgroup

OS in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)

Posted

Median

95% Confidence Interval

Months

Baseline until death (up to approximately 34 months)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

OS in Arm A Versus Arm C by PD-L1 Subgroup

OS in Arm A Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)

PD-L1 WT populations are defined as the PD-L1 populations (TC2/3 or IC2/3 population or TC1/2/3 or IC1/2/3 population) excluding patients with an activating EGFR mutation or ALK translocation.

Posted

Median

95% Confidence Interval

Months

Baseline until death (up approximately 53 months)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population

Teff-high WT population, defined as the Teff-high population excluding patients with activating EGFR mutation or ALK translocation. Teff-high population, defined as participants in the ITT population with Teff signature expression >=-1.91. ITT population, defined as all randomized patients, regardless of receipt of the assigned treatment.

Posted

Median

95% Confidence Interval

Months

Baseline until death (up to approximately 34 months)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population

Teff-high WT population, defined as Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. Teff-high population, defined as patients in the ITT population with Teff signature expression >=-1.91. ITT population is defined as all randomized patients, regardless of receipt of the assigned treatment.

Posted

Median

95% Confidence Interval

Months

Baseline until death (up approximately 53 months)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population

Posted

Median

95% Confidence Interval

Months

Baseline until death (up approximately 53 months)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Secondary

Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C

DOR, as determined by investigator according to RECIST v1.1 in Arm B versus Arm C in the Teff high-WT population and the ITT-WT population.

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population

Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator using RECIST v1.1 in the Teff-High-WT population and ITT-WT population.

Posted

Number

Percentage

Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Secondary

OS Rates at Years 1 and 2 in Arm B Versus Arm C

OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.

Posted

Number

95% Confidence Interval

Percentage

Baseline to 2 years or death, whichever occurs first.

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

OS Rates at Years 1 and 2 in Arm A Versus Arm C

OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.

Posted

Number

95% Confidence Interval

Percentage

Baseline to 2 years or death, whichever occurs first.

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score

EORTC QLQ-C30 is a validated & reliable self-report measure (Aaronson et al.1993;Fitzsimmons et al.1999) that consists of 30 questions that assess 5 aspects of patient functioning (physical,emotional,role, cognitive,and social), 3 symptom scales (fatigue,nausea & vomiting, pain),global health/quality of life,and six single items (dyspnea,insomnia, appetite loss,constipation,diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life);however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al.1998).

Posted

Median

95% Confidence Interval

Months

Baseline up to approximately 29 months

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

Secondary

TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score

QLQ-LC13 Quality-of-Life Questionnaire Lung Cancer Module incorporates one multiple-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).

Posted

Median

95% Confidence Interval

Months

Baseline up to approximately 29 months

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

Secondary

Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale

The SILC (Symptoms in Lung Cancer) scale was used to assess patient-reported severity of lung cancer symptoms (chest pain, dyspnea, and cough). The SILC scale is a 9-item content validated self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a symptom severity score. The SILC questionnaire comprises three individual symptoms (dyspnea, cough, chest pain) and are scored at the individual symptom level, thus have a dyspnea score, chest pain score, and cough score. Each individual symptom score is calculated as the average of responses for the symptom items [e.g. Chest Pain Score=mean (item 1; item 2)]. An increase in score is suggestive of a worsening in symptomology (i.e. frequency or severity). A score change of ≥0.3 points for the dyspnea and cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for the chest pain score is considered to be clinically significant.

No participants were analyzed due to psychometric properties within the NSCLC population are still being determined. Due to quality issues data not analyzed.

Posted

Baseline up to approximately 29 months

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

Secondary

Percentage of Participants With Adverse Events

Percentage of participants with at least one adverse event.

Safety population included all treated patients, defined as randomized patients who received any amount of any component of study treatment.

Posted

Number

Percentage

Baseline up to data cutoff date 7 December 2020 (up to approximately 68 months)

ID	Title	Description
OG000	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
OG001	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Secondary

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

The baseline ADA-evaluable population for each study treatment included patients who had a baseline ADA result. The post-baseline ADA-evaluable population for each study treatment included patients who had at least one post-baseline ADA result and had received at least on dose of that study treatment.

Posted

Number

Percentage of Participants

Baseline up to approximately 29 months

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Secondary

Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B

The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.

The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Posted

Mean

Standard Deviation

mcg/mL

Day 1 of Cycle 1 and 3 (Cycle length=21 days)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Secondary

Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B

The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Posted

Mean

Standard Deviation

mcg/mL

Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Secondary

Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C

The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Posted

Mean

Standard Deviation

ng/mL

Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (Cycle length=21 days)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Secondary

Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C

The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Posted

Mean

Standard Deviation

ng/mL

Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (Cycle length=21 days)

ID	Title	Description
OG000	Arm A (Atezolizumab+Paclitaxel+Carboplatin)	Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
OG001	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

Secondary

Cmax of Bevacizumab in Arm B and Arm C

The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Posted

Mean

Standard Deviation

mcg/mL

Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Secondary

Cmin of Bevacizumab in Arm B and Arm C

The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.

Posted

Mean

Standard Deviation

mcg/mL

Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days)

ID	Title	Description
OG000	Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
OG001	Arm C (Bevacizumab+Paclitaxel+Carboplatin)	Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0004 events4 affected394 at risk EG0015 events5 affected393 at risk EG0026 events5 affected400 at risk
BONE MARROW FAILURE	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG00018 events17 affected394 at risk EG00130 events27 affected393 at risk EG00213 events13 affected400 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
MYELOSUPPRESSION	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0014 events4 affected393 at risk EG0021 events1 affected400 at risk
NORMOCHROMIC ANAEMIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
SPONTANEOUS HAEMATOMA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0016 events6 affected393 at risk EG0021 events1 affected400 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events2 affected393 at risk EG0022 events2 affected400 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
AUTOIMMUNE MYOCARDITIS	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0013 events1 affected393 at risk EG0022 events2 affected400 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PERICARDITIS	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
TACHYARRHYTHMIA	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
ADRENOCORTICAL INSUFFICIENCY ACUTE	Endocrine disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
DIABETES INSIPIDUS	Endocrine disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
HYPOPHYSITIS	Endocrine disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	Endocrine disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
SECONDARY ADRENOCORTICAL INSUFFICIENCY	Endocrine disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
OPTIC NEUROPATHY	Eye disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected394 at risk EG0011 events1 affected393 at risk EG0022 events2 affected400 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
COLITIS	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0016 events6 affected393 at risk EG0021 events1 affected400 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected394 at risk EG00111 events10 affected393 at risk EG0028 events8 affected400 at risk
DIVERTICULAR PERFORATION	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0023 events2 affected400 at risk
FAECALOMA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
FOOD POISONING	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0014 events4 affected393 at risk EG0020 events0 affected400 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0022 events2 affected400 at risk
GLOSSODYNIA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
INTESTINAL ANGINA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events1 affected393 at risk EG0020 events0 affected400 at risk
INTESTINAL INFARCTION	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
LARGE INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
NAUSEA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected394 at risk EG0017 events7 affected393 at risk EG0021 events1 affected400 at risk
OESOPHAGEAL FOOD IMPACTION	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
VOMITING	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected394 at risk EG0015 events5 affected393 at risk EG0025 events4 affected400 at risk
ASTHENIA	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
CATHETER SITE ERYTHEMA	General disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
CHEST PAIN	General disorders	MedDRA version 23.1	Systematic Assessment	EG0007 events6 affected394 at risk EG0014 events4 affected393 at risk EG0022 events1 affected400 at risk
COMPLICATION ASSOCIATED WITH DEVICE	General disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
DEATH	General disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
INFUSION SITE EXTRAVASATION	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PAIN	General disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
PYREXIA	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0018 events8 affected393 at risk EG0026 events6 affected400 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0013 events3 affected393 at risk EG0020 events0 affected400 at risk
CHOLANGITIS ACUTE	Hepatobiliary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
HEPATITIS	Hepatobiliary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
HEPATOMEGALY	Hepatobiliary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
HEPATOTOXICITY	Hepatobiliary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0022 events2 affected400 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events1 affected393 at risk EG0022 events2 affected400 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0012 events1 affected393 at risk EG0021 events1 affected400 at risk
ABDOMINAL SEPSIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
ANAL ABSCESS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
BACTERAEMIA	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
BONE ABSCESS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
BRONCHITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0014 events4 affected393 at risk EG0021 events1 affected400 at risk
BURSITIS INFECTIVE	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
CELLULITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
CHRONIC SINUSITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0022 events2 affected400 at risk
DIVERTICULITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events1 affected393 at risk EG0021 events1 affected400 at risk
EMPYEMA	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0022 events2 affected400 at risk
ENCEPHALITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
ENDOCARDITIS BACTERIAL	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
ENTERITIS INFECTIOUS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
ENTEROCOLITIS BACTERIAL	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
FEBRILE INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
GASTROENTERITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
GASTROENTERITIS CLOSTRIDIAL	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
HAEMORRHAGIC PNEUMONIA	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
HEPATITIS A	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HEPATITIS C	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HERPES ZOSTER	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0022 events2 affected400 at risk
INFECTED SKIN ULCER	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
INFECTIOUS PLEURAL EFFUSION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
INFLUENZA	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
KLEBSIELLA SEPSIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
LARGE INTESTINE INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0024 events3 affected400 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
PARAINFLUENZAE VIRUS INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PAROTITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PNEUMONIA	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG00019 events18 affected394 at risk EG00130 events28 affected393 at risk EG00223 events21 affected400 at risk
PNEUMONIA ADENOVIRAL	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0013 events3 affected393 at risk EG0020 events0 affected400 at risk
PROSTATIC ABSCESS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PYOPNEUMOTHORAX	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
RESPIRATORY SYNCYTIAL VIRUS INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected394 at risk EG0014 events4 affected393 at risk EG0022 events2 affected400 at risk
RESPIRATORY TRACT INFECTION FUNGAL	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
SALMONELLOSIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
SCROTAL ABSCESS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
SEPSIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0005 events5 affected394 at risk EG0014 events3 affected393 at risk EG0023 events3 affected400 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0022 events2 affected400 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
TOOTH ABSCESS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected394 at risk EG0013 events3 affected393 at risk EG0024 events4 affected400 at risk
VASCULAR DEVICE INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
VIRAL INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0013 events3 affected393 at risk EG0020 events0 affected400 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
FALL	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0022 events2 affected400 at risk
FRACTURE	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0022 events2 affected400 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0023 events3 affected400 at risk
PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
STERNAL FRACTURE	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
BLOOD PRESSURE INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
GENERAL PHYSICAL CONDITION ABNORMAL	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
LIPASE INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
TRANSAMINASES INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
TROPONIN INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
WEIGHT DECREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0006 events6 affected394 at risk EG0019 events7 affected393 at risk EG0023 events3 affected400 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0012 events2 affected393 at risk EG0023 events3 affected400 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
COMPARTMENT SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0022 events2 affected400 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
OSTEOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
SOFT TISSUE NECROSIS	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
SPINAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
VERTEBRAL FORAMINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
ADENOCARCINOMA GASTRIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
BLADDER TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
MARROW HYPERPLASIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
MENINGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
METASTASES TO MENINGES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
TUMOUR PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
TUMOUR PSEUDOPROGRESSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
ATAXIA	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0015 events5 affected393 at risk EG0022 events2 affected400 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
DEPRESSED LEVEL OF CONSCIOUSNESS	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
DIZZINESS	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
DIZZINESS POSTURAL	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
DYSAESTHESIA	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
FOCAL DYSCOGNITIVE SEIZURES	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
HEADACHE	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
HEMIPARESIS	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0004 events4 affected394 at risk EG0011 events1 affected393 at risk EG0022 events2 affected400 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PARTIAL SEIZURES	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0022 events2 affected400 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
PRESYNCOPE	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
SEIZURE	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0015 events5 affected393 at risk EG0023 events2 affected400 at risk
SOMNOLENCE	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
SYNCOPE	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
ALCOHOL WITHDRAWAL SYNDROME	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
ANXIETY	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events1 affected393 at risk EG0020 events0 affected400 at risk
BIPOLAR DISORDER	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
DELIRIUM	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
DELUSION	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected394 at risk EG0013 events3 affected393 at risk EG0022 events2 affected400 at risk
GLOMERULONEPHROPATHY	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
PRERENAL FAILURE	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0013 events3 affected393 at risk EG0020 events0 affected400 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0022 events1 affected400 at risk
RENAL INJURY	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
TUBULOINTERSTITIAL NEPHRITIS	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0023 events3 affected400 at risk
BRONCHOSTENOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0013 events3 affected393 at risk EG0023 events3 affected400 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0013 events3 affected393 at risk EG0020 events0 affected400 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0006 events6 affected394 at risk EG0012 events2 affected393 at risk EG0024 events4 affected400 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events1 affected393 at risk EG0020 events0 affected400 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0018 events8 affected393 at risk EG0024 events3 affected400 at risk
HICCUPS	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events2 affected393 at risk EG0022 events2 affected400 at risk
IMMUNE-MEDIATED PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected394 at risk EG0010 events0 affected393 at risk EG0023 events3 affected400 at risk
PLEURISY	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events1 affected393 at risk EG0021 events1 affected400 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0017 events7 affected393 at risk EG0028 events8 affected400 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events2 affected394 at risk EG0010 events0 affected393 at risk EG0024 events4 affected400 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0008 events8 affected394 at risk EG0015 events5 affected393 at risk EG0028 events8 affected400 at risk
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0004 events4 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
PULMONARY NECROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0022 events2 affected400 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
ERYTHEMA MULTIFORME	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0023 events3 affected400 at risk
PEMPHIGOID	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events1 affected393 at risk EG0023 events3 affected400 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
VERTEBROPLASTY	Surgical and medical procedures	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
ANEURYSM	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
AORTIC DISSECTION	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0020 events0 affected400 at risk
ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
DIABETIC VASCULAR DISORDER	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
EMBOLISM	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0022 events2 affected400 at risk
EMBOLISM VENOUS	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
HAEMATOMA	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HYPERTENSION	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
HYPOTENSION	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
LYMPHOEDEMA	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk
PERIPHERAL ARTERY THROMBOSIS	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0020 events0 affected400 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0011 events1 affected393 at risk EG0021 events1 affected400 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0010 events0 affected393 at risk EG0020 events0 affected400 at risk
THROMBOSIS	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected394 at risk EG0012 events2 affected393 at risk EG0021 events1 affected400 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected394 at risk EG0010 events0 affected393 at risk EG0021 events1 affected400 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG000124 events104 affected394 at risk EG001134 events116 affected393 at risk EG002183 events146 affected400 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG00017 events14 affected394 at risk EG00120 events14 affected393 at risk EG00235 events20 affected400 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG000107 events70 affected394 at risk EG001111 events72 affected393 at risk EG00285 events60 affected400 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG00064 events45 affected394 at risk EG00174 events53 affected393 at risk EG00278 events49 affected400 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA version 23.1	Systematic Assessment	EG00013 events13 affected394 at risk EG00156 events50 affected393 at risk EG00240 events33 affected400 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG00024 events20 affected394 at risk EG00148 events36 affected393 at risk EG00236 events29 affected400 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG000115 events92 affected394 at risk EG001151 events122 affected393 at risk EG002128 events103 affected400 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG000133 events98 affected394 at risk EG001221 events125 affected393 at risk EG002137 events82 affected400 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0006 events6 affected394 at risk EG00122 events20 affected393 at risk EG00216 events13 affected400 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG00011 events9 affected394 at risk EG00120 events20 affected393 at risk EG00213 events11 affected400 at risk
NAUSEA	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG000177 events124 affected394 at risk EG001223 events149 affected393 at risk EG002210 events130 affected400 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG00030 events24 affected394 at risk EG00173 events54 affected393 at risk EG00227 events23 affected400 at risk
VOMITING	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG000105 events67 affected394 at risk EG00199 events71 affected393 at risk EG00292 events69 affected400 at risk
ASTHENIA	General disorders	MedDRA version 23.1	Systematic Assessment	EG000107 events80 affected394 at risk EG001143 events84 affected393 at risk EG002127 events76 affected400 at risk
CHEST PAIN	General disorders	MedDRA version 23.1	Systematic Assessment	EG00032 events28 affected394 at risk EG00137 events35 affected393 at risk EG00244 events38 affected400 at risk
FATIGUE	General disorders	MedDRA version 23.1	Systematic Assessment	EG000125 events107 affected394 at risk EG001157 events137 affected393 at risk EG002129 events111 affected400 at risk
MALAISE	General disorders	MedDRA version 23.1	Systematic Assessment	EG00013 events11 affected394 at risk EG00143 events27 affected393 at risk EG00227 events20 affected400 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA version 23.1	Systematic Assessment	EG00027 events24 affected394 at risk EG00142 events38 affected393 at risk EG00210 events10 affected400 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA version 23.1	Systematic Assessment	EG00020 events19 affected394 at risk EG00142 events35 affected393 at risk EG00233 events29 affected400 at risk
PAIN	General disorders	MedDRA version 23.1	Systematic Assessment	EG00017 events17 affected394 at risk EG00131 events26 affected393 at risk EG00223 events22 affected400 at risk
PYREXIA	General disorders	MedDRA version 23.1	Systematic Assessment	EG00044 events34 affected394 at risk EG00188 events67 affected393 at risk EG00266 events53 affected400 at risk
BRONCHITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG00017 events16 affected394 at risk EG00137 events28 affected393 at risk EG00216 events15 affected400 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG00018 events17 affected394 at risk EG00134 events27 affected393 at risk EG00250 events31 affected400 at risk
PNEUMONIA	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG00017 events15 affected394 at risk EG00122 events19 affected393 at risk EG00223 events21 affected400 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG00020 events16 affected394 at risk EG00156 events37 affected393 at risk EG00243 events24 affected400 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG00037 events28 affected394 at risk EG00157 events35 affected393 at risk EG00251 events37 affected400 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG00024 events20 affected394 at risk EG00145 events30 affected393 at risk EG00226 events22 affected400 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG00019 events18 affected394 at risk EG00148 events30 affected393 at risk EG00229 events22 affected400 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG00072 events34 affected394 at risk EG00187 events49 affected393 at risk EG00264 events33 affected400 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG00076 events44 affected394 at risk EG00184 events57 affected393 at risk EG00259 events41 affected400 at risk
WEIGHT DECREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG00046 events42 affected394 at risk EG00156 events52 affected393 at risk EG00232 events29 affected400 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA version 23.1	Systematic Assessment	EG00039 events20 affected394 at risk EG00142 events26 affected393 at risk EG00227 events17 affected400 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG000102 events86 affected394 at risk EG001157 events119 affected393 at risk EG002129 events100 affected400 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG00016 events15 affected394 at risk EG00142 events33 affected393 at risk EG0027 events7 affected400 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG00018 events16 affected394 at risk EG00147 events36 affected393 at risk EG00230 events24 affected400 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG00029 events25 affected394 at risk EG00176 events55 affected393 at risk EG00249 events38 affected400 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG00020 events17 affected394 at risk EG00132 events23 affected393 at risk EG00214 events13 affected400 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG000155 events102 affected394 at risk EG001227 events130 affected393 at risk EG002175 events105 affected400 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG00050 events43 affected394 at risk EG00167 events57 affected393 at risk EG00270 events51 affected400 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG00019 events19 affected394 at risk EG00133 events23 affected393 at risk EG00218 events16 affected400 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0008 events7 affected394 at risk EG00124 events20 affected393 at risk EG00210 events10 affected400 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG00081 events53 affected394 at risk EG001118 events69 affected393 at risk EG002104 events67 affected400 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG00043 events32 affected394 at risk EG00163 events50 affected393 at risk EG00252 events45 affected400 at risk
DIZZINESS	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG00031 events26 affected394 at risk EG00134 events27 affected393 at risk EG00239 events28 affected400 at risk
DYSGEUSIA	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG00024 events19 affected394 at risk EG00127 events24 affected393 at risk EG00216 events15 affected400 at risk
HEADACHE	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG00065 events53 affected394 at risk EG00187 events70 affected393 at risk EG00249 events41 affected400 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG00077 events67 affected394 at risk EG001105 events92 affected393 at risk EG002117 events104 affected400 at risk
PARAESTHESIA	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG00050 events44 affected394 at risk EG00159 events53 affected393 at risk EG00242 events37 affected400 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG00059 events54 affected394 at risk EG00173 events65 affected393 at risk EG00265 events58 affected400 at risk
ANXIETY	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG00023 events22 affected394 at risk EG00131 events31 affected393 at risk EG00223 events23 affected400 at risk
DEPRESSION	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG00013 events13 affected394 at risk EG00126 events25 affected393 at risk EG00216 events15 affected400 at risk
INSOMNIA	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG00041 events38 affected394 at risk EG00143 events42 affected393 at risk EG00256 events50 affected400 at risk
PROTEINURIA	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG00081 events63 affected394 at risk EG001128 events80 affected393 at risk EG00213 events9 affected400 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG00094 events77 affected394 at risk EG001107 events86 affected393 at risk EG00299 events82 affected400 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG00019 events18 affected394 at risk EG00127 events27 affected393 at risk EG00212 events11 affected400 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG00066 events60 affected394 at risk EG00181 events67 affected393 at risk EG002107 events86 affected400 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG000108 events86 affected394 at risk EG00189 events67 affected393 at risk EG00222 events17 affected400 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG00021 events18 affected394 at risk EG00124 events21 affected393 at risk EG00227 events16 affected400 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG00010 events10 affected394 at risk EG00125 events22 affected393 at risk EG00210 events9 affected400 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG000183 events180 affected394 at risk EG001195 events188 affected393 at risk EG002182 events180 affected400 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0009 events9 affected394 at risk EG00131 events29 affected393 at risk EG00228 events24 affected400 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG00029 events25 affected394 at risk EG00176 events58 affected393 at risk EG00272 events52 affected400 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG00034 events28 affected394 at risk EG00192 events72 affected393 at risk EG00294 events71 affected400 at risk
HYPERTENSION	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG000102 events87 affected394 at risk EG001149 events104 affected393 at risk EG00216 events16 affected400 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Arm C	Bevacizumab+Paclitaxel+Carboplatin
BG001	Arm B	Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin
BG002	Arm A	Atezolizumab+Paclitaxel+Carboplatin
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm C (Bev+CP)	Bevacizumab+Paclitaxel+Carboplatin	311	394	142	394	381	394
EG001	Arm B (Atezo+Bev+CP)	Atezolizumab+Bevacizumab+Paclitaxel+Carboplatin	285	393	190	393	375	393
EG002	Arm A (Atezo+CP)	Atezolizumab+Paclitaxel+Carboplatin	293	400	170	400	385	400

ID	Term
C000594389	atezolizumab
D000068258	Bevacizumab
D016190	Carboplatin
D017239	Paclitaxel