Study of Nivolumab Versus Placebo in Combination With Neo... | NCT04109066

Label	Type	Description	Intervention Names
Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET	Experimental	Nivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice	Biological: nivolumab Drug: paclitaxel (PTX) Drug: anthracycline Drug: cyclophosphamide Drug: Endocrine Therapy Procedure: Surgery
Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET	Placebo Comparator	Nivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then adjuvant (post-surgery) endocrine therapy of investigator's choice	Drug: paclitaxel (PTX) Other: nivolumab placebo Drug: anthracycline Drug: cyclophosphamide Drug: Endocrine Therapy Procedure: Surgery

Name	Type	Description	Arm Group Labels	Other Names
nivolumab	Biological	Specified Dose on Specified days	Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET

Measure	Description	Time Frame
Pathological Complete Response (pCR) Rate	pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.	Up to approximately 37 months

Measure	Description	Time Frame
Pathological Complete Response (pCR) Rate (PD-L1 >=1%)	pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0136		Mobile	Alabama	36604	United States
Local Institution - 0052

PubMed Identifier	Type	Citation	Retractions
39838118	Derived	Loi S, Salgado R, Curigliano G, Romero Diaz RI, Delaloge S, Rojas Garcia CI, Kok M, Saura C, Harbeck N, Mittendorf EA, Yardley DA, Suarez Zaizar A, Caminos FR, Ungureanu A, Reinoso-Toledo JG, Guarneri V, Egle D, Ades F, Pacius M, Chhibber A, Chandra R, Nathani R, Spires T, Wu JQ, Pusztai L, McArthur H. Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial. Nat Med. 2025 Feb;31(2):433-441. doi: 10.1038/s41591-024-03414-8. Epub 2025 Jan 21.
38913933

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Arm A	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 27, 2022

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

Pathological Complete Response (pCR) Rate

pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.

All randomized participants with sufficient follow-up for pCR assessment

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 37 months

ID	Title	Description
OG000	Arm A	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
OG001	Arm B	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)

Units	Counts
Participants	OG000257 OG001253

Title

Denominators

Categories

Title	Measurements
	OG00024.5(19.4 to 30.2) OG00113.8(9.8 to 18.7)

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	Arm A over Arm B	Cochran-Mantel-Haenszel		0.0021		Odds Ratio (OR)	2.05			2-Sided	95	1.29	3.27			Stratified by PD-L1 by SP142 (< 1% vs. >= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT. Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method.		Superiority

Secondary

Pathological Complete Response (pCR) Rate (PD-L1 >=1%)

All randomized participants in PD-L1 expression on immune cells >=1% subgroup with sufficient follow-up for pCR assessment

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 37 months

ID	Title	Description
OG000	Arm A	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
OG001	Arm B	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)

Secondary

Number of Participants With Residual Cancer Burden (RCB)

RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.

All randomized participants with sufficient follow-up for RCB assessment

Posted

Count of Participants

Participants

Up to approximately 37 months

ID	Title	Description
OG000	Arm A	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
OG001	Arm B	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)

Secondary

Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%

All randomized participants in PD-L1 expression on immune cells >=1% subgroup with sufficient follow-up for RCB assessment

Posted

Count of Participants

Participants

Up to approximately 37 months

ID	Title	Description
OG000	Arm A	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
OG001	Arm B	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)

Secondary

Number of Participants With Adverse Events (AEs)

Number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

All treated participants

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)

ID	Title	Description
OG000	Arm A	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
OG001	Arm B	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)

Secondary

Number of Participants With Serious Adverse Events (SAEs)

Number of participants with any grade serious adverse events (SAE). SAE is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires inpatient hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

All treated participants

Posted

Count of Participants

Participants

From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)

ID	Title	Description
OG000	Arm A	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
OG001	Arm B	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)

Secondary

Number of Participants Who Died

Number of participants who died due to any cause.

All treated participants

Posted

Count of Participants

Participants

Up to approximately 41 months

ID	Title	Description
OG000	Arm A	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
OG001	Arm B	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)

Units	Counts
Participants

Arm/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 A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + AC Q3W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)	8	129	38	127	126	127
EG001	Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W): Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)	7	136	51	135	132	135
EG002	Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + AC Q3W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)	4	124	20	123	120	123
EG003	Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W): Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)	4	132	26	132	130	132

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0002 affected127 at risk EG0012 affected135 at risk EG0020 affected123 at risk EG0030 affected132 at risk
Febrile neutropenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG0019 affected135 at risk EG0020 affected123 at risk EG003
Leukopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Myelosuppression	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Neutropenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0002 affected127 at risk EG0012 affected135 at risk EG0022 affected123 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Cardiac failure	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Cardiac failure congestive	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Cardiac perfusion defect	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Left ventricular failure	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Myocardial infarction	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Myocarditis	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Pericardial effusion	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Supraventricular tachycardia	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Vertigo	Ear and labyrinth disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Adrenal insufficiency	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Hypopituitarism	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Immune-mediated adrenal insufficiency	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Thyroiditis subacute	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Abdominal pain	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Colitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Diarrhoea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0022 affected123 at risk EG003
Gastritis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Nausea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Pancreatitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Vomiting	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Death	General disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Disease progression	General disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Malaise	General disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Non-cardiac chest pain	General disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Pyrexia	General disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0014 affected135 at risk EG0020 affected123 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Cholecystitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Cholelithiasis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Hepatitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Hepatitis cholestatic	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Anaphylactic reaction	Immune system disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Anaphylactic shock	Immune system disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Breast abscess	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Breast cellulitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0012 affected135 at risk EG0021 affected123 at risk EG003
COVID-19	Infections and infestations	26.1	Systematic Assessment	EG0002 affected127 at risk EG0015 affected135 at risk EG0022 affected123 at risk EG003
COVID-19 pneumonia	Infections and infestations	26.1	Systematic Assessment	EG0003 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Catheter site infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Cellulitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Cystitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Device related infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0021 affected123 at risk EG003
Enterocolitis infectious	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Mastitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Neutropenic infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0021 affected123 at risk EG003
Neutropenic sepsis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Perirectal abscess	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Pneumocystis jirovecii infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Pneumonia	Infections and infestations	26.1	Systematic Assessment	EG0001 affected127 at risk EG0013 affected135 at risk EG0021 affected123 at risk EG003
Pneumonia bacterial	Infections and infestations	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Postoperative wound infection	Infections and infestations	26.1	Systematic Assessment	EG0002 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Pulmonary tuberculosis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
SARS-CoV-2 sepsis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Sepsis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Septic shock	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Skin infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Systemic infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Upper respiratory tract infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Urinary tract infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Vascular access site infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Vascular device infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Wound infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0021 affected123 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Craniofacial fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0021 affected123 at risk EG003
Radiation skin injury	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected127 at risk EG0012 affected135 at risk EG0020 affected123 at risk EG003
Surgical procedure repeated	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected127 at risk EG0012 affected135 at risk EG0020 affected123 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Blood creatinine increased	Investigations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Inflammatory marker increased	Investigations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Liver function test increased	Investigations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Neutrophil count decreased	Investigations	26.1	Systematic Assessment	EG0001 affected127 at risk EG0012 affected135 at risk EG0020 affected123 at risk EG003
White blood cell count decreased	Investigations	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Dehydration	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0012 affected135 at risk EG0020 affected123 at risk EG003
Hypophagia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0002 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Cerebellar syndrome	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Epilepsy	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Headache	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Intracranial pressure increased	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Syncope	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0021 affected123 at risk EG003
Device occlusion	Product Issues	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Confusional state	Psychiatric disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Acute kidney injury	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0021 affected123 at risk EG003
Glomerulonephritis	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Urinary retention	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Breast inflammation	Reproductive system and breast disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0012 affected135 at risk EG0020 affected123 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0012 affected135 at risk EG0020 affected123 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0002 affected127 at risk EG0012 affected135 at risk EG0020 affected123 at risk EG003
Pemphigoid	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Rash	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0020 affected123 at risk EG003
Arterial thrombosis	Vascular disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Deep vein thrombosis	Vascular disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0011 affected135 at risk EG0021 affected123 at risk EG003
Embolism	Vascular disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003
Hypotension	Vascular disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0010 affected135 at risk EG0020 affected123 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG00047 affected127 at risk EG00165 affected135 at risk EG00232 affected123 at risk EG00362 affected132 at risk
Leukopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0008 affected127 at risk EG0018 affected135 at risk EG00212 affected123 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG00015 affected127 at risk EG0019 affected135 at risk EG0028 affected123 at risk EG003
Neutropenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG00024 affected127 at risk EG00126 affected135 at risk EG00227 affected123 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0002 affected127 at risk EG0017 affected135 at risk EG0021 affected123 at risk EG003
Palpitations	Cardiac disorders	26.1	Systematic Assessment	EG0002 affected127 at risk EG0016 affected135 at risk EG0021 affected123 at risk EG003
Tachycardia	Cardiac disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG0018 affected135 at risk EG0020 affected123 at risk EG003
Adrenal insufficiency	Endocrine disorders	26.1	Systematic Assessment	EG0005 affected127 at risk EG00110 affected135 at risk EG0020 affected123 at risk EG003
Hyperthyroidism	Endocrine disorders	26.1	Systematic Assessment	EG0007 affected127 at risk EG00113 affected135 at risk EG0022 affected123 at risk EG003
Hypothyroidism	Endocrine disorders	26.1	Systematic Assessment	EG00019 affected127 at risk EG00130 affected135 at risk EG0028 affected123 at risk EG003
Dry eye	Eye disorders	26.1	Systematic Assessment	EG0004 affected127 at risk EG00110 affected135 at risk EG0024 affected123 at risk EG003
Lacrimation increased	Eye disorders	26.1	Systematic Assessment	EG0004 affected127 at risk EG0017 affected135 at risk EG0025 affected123 at risk EG003
Abdominal pain	Gastrointestinal disorders	26.1	Systematic Assessment	EG0006 affected127 at risk EG00115 affected135 at risk EG0029 affected123 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	26.1	Systematic Assessment	EG0007 affected127 at risk EG00112 affected135 at risk EG0024 affected123 at risk EG003
Constipation	Gastrointestinal disorders	26.1	Systematic Assessment	EG00023 affected127 at risk EG00136 affected135 at risk EG00219 affected123 at risk EG003
Diarrhoea	Gastrointestinal disorders	26.1	Systematic Assessment	EG00030 affected127 at risk EG00148 affected135 at risk EG00226 affected123 at risk EG003
Dry mouth	Gastrointestinal disorders	26.1	Systematic Assessment	EG0005 affected127 at risk EG0019 affected135 at risk EG0024 affected123 at risk EG003
Dyspepsia	Gastrointestinal disorders	26.1	Systematic Assessment	EG0009 affected127 at risk EG00110 affected135 at risk EG0025 affected123 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	26.1	Systematic Assessment	EG0004 affected127 at risk EG0019 affected135 at risk EG0022 affected123 at risk EG003
Nausea	Gastrointestinal disorders	26.1	Systematic Assessment	EG00061 affected127 at risk EG00177 affected135 at risk EG00255 affected123 at risk EG003
Stomatitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0004 affected127 at risk EG00114 affected135 at risk EG0024 affected123 at risk EG003
Vomiting	Gastrointestinal disorders	26.1	Systematic Assessment	EG00026 affected127 at risk EG00127 affected135 at risk EG00225 affected123 at risk EG003
Asthenia	General disorders	26.1	Systematic Assessment	EG00027 affected127 at risk EG00125 affected135 at risk EG00230 affected123 at risk EG003
Chills	General disorders	26.1	Systematic Assessment	EG0001 affected127 at risk EG0018 affected135 at risk EG0021 affected123 at risk EG003
Fatigue	General disorders	26.1	Systematic Assessment	EG00034 affected127 at risk EG00167 affected135 at risk EG00224 affected123 at risk EG003
Illness	General disorders	26.1	Systematic Assessment	EG0007 affected127 at risk EG0010 affected135 at risk EG0022 affected123 at risk EG003
Mucosal inflammation	General disorders	26.1	Systematic Assessment	EG0007 affected127 at risk EG00116 affected135 at risk EG0026 affected123 at risk EG003
Oedema peripheral	General disorders	26.1	Systematic Assessment	EG0005 affected127 at risk EG00112 affected135 at risk EG0026 affected123 at risk EG003
Pain	General disorders	26.1	Systematic Assessment	EG0005 affected127 at risk EG00111 affected135 at risk EG0022 affected123 at risk EG003
Pyrexia	General disorders	26.1	Systematic Assessment	EG00011 affected127 at risk EG00121 affected135 at risk EG0027 affected123 at risk EG003
Hypersensitivity	Immune system disorders	26.1	Systematic Assessment	EG0008 affected127 at risk EG0013 affected135 at risk EG0025 affected123 at risk EG003
COVID-19	Infections and infestations	26.1	Systematic Assessment	EG00021 affected127 at risk EG00129 affected135 at risk EG00218 affected123 at risk EG003
Folliculitis	Infections and infestations	26.1	Systematic Assessment	EG0006 affected127 at risk EG0019 affected135 at risk EG0021 affected123 at risk EG003
Nasopharyngitis	Infections and infestations	26.1	Systematic Assessment	EG0004 affected127 at risk EG0016 affected135 at risk EG0021 affected123 at risk EG003
Upper respiratory tract infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected127 at risk EG0017 affected135 at risk EG0028 affected123 at risk EG003
Urinary tract infection	Infections and infestations	26.1	Systematic Assessment	EG00012 affected127 at risk EG0018 affected135 at risk EG0029 affected123 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG00012 affected127 at risk EG00125 affected135 at risk EG00210 affected123 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0003 affected127 at risk EG0019 affected135 at risk EG0025 affected123 at risk EG003
Radiation skin injury	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG00015 affected127 at risk EG00122 affected135 at risk EG00213 affected123 at risk EG003
Alanine aminotransferase increased	Investigations	26.1	Systematic Assessment	EG00027 affected127 at risk EG00131 affected135 at risk EG00223 affected123 at risk EG003
Aspartate aminotransferase increased	Investigations	26.1	Systematic Assessment	EG00032 affected127 at risk EG00130 affected135 at risk EG00223 affected123 at risk EG003
Blood alkaline phosphatase increased	Investigations	26.1	Systematic Assessment	EG00010 affected127 at risk EG0019 affected135 at risk EG0024 affected123 at risk EG003
Blood calcium increased	Investigations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0017 affected135 at risk EG0020 affected123 at risk EG003
Blood glucose increased	Investigations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0017 affected135 at risk EG0020 affected123 at risk EG003
Blood lactate dehydrogenase increased	Investigations	26.1	Systematic Assessment	EG0006 affected127 at risk EG0016 affected135 at risk EG0025 affected123 at risk EG003
Blood sodium decreased	Investigations	26.1	Systematic Assessment	EG0000 affected127 at risk EG0018 affected135 at risk EG0020 affected123 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	26.1	Systematic Assessment	EG0004 affected127 at risk EG00111 affected135 at risk EG0020 affected123 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	26.1	Systematic Assessment	EG0005 affected127 at risk EG00115 affected135 at risk EG0023 affected123 at risk EG003
Lymphocyte count decreased	Investigations	26.1	Systematic Assessment	EG0004 affected127 at risk EG0019 affected135 at risk EG0022 affected123 at risk EG003
Neutrophil count decreased	Investigations	26.1	Systematic Assessment	EG00020 affected127 at risk EG00116 affected135 at risk EG00211 affected123 at risk EG003
Weight decreased	Investigations	26.1	Systematic Assessment	EG0007 affected127 at risk EG00110 affected135 at risk EG0023 affected123 at risk EG003
White blood cell count decreased	Investigations	26.1	Systematic Assessment	EG00015 affected127 at risk EG0019 affected135 at risk EG0028 affected123 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG00016 affected127 at risk EG00119 affected135 at risk EG00213 affected123 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG00015 affected127 at risk EG00113 affected135 at risk EG0028 affected123 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0004 affected127 at risk EG00112 affected135 at risk EG0020 affected123 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0004 affected127 at risk EG0013 affected135 at risk EG0022 affected123 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG00021 affected127 at risk EG00141 affected135 at risk EG00220 affected123 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0008 affected127 at risk EG00116 affected135 at risk EG0025 affected123 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG00112 affected135 at risk EG0024 affected123 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG00014 affected127 at risk EG00126 affected135 at risk EG00213 affected123 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0007 affected127 at risk EG00114 affected135 at risk EG0028 affected123 at risk EG003
Dizziness	Nervous system disorders	26.1	Systematic Assessment	EG0009 affected127 at risk EG00110 affected135 at risk EG0027 affected123 at risk EG003
Dysgeusia	Nervous system disorders	26.1	Systematic Assessment	EG0009 affected127 at risk EG00126 affected135 at risk EG0028 affected123 at risk EG003
Headache	Nervous system disorders	26.1	Systematic Assessment	EG00024 affected127 at risk EG00143 affected135 at risk EG00224 affected123 at risk EG003
Neuropathy peripheral	Nervous system disorders	26.1	Systematic Assessment	EG00026 affected127 at risk EG00138 affected135 at risk EG00219 affected123 at risk EG003
Paraesthesia	Nervous system disorders	26.1	Systematic Assessment	EG0008 affected127 at risk EG00110 affected135 at risk EG0028 affected123 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	26.1	Systematic Assessment	EG0008 affected127 at risk EG00121 affected135 at risk EG00210 affected123 at risk EG003
Taste disorder	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0013 affected135 at risk EG0021 affected123 at risk EG003
Anxiety	Psychiatric disorders	26.1	Systematic Assessment	EG0006 affected127 at risk EG00110 affected135 at risk EG0022 affected123 at risk EG003
Depression	Psychiatric disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG0017 affected135 at risk EG0020 affected123 at risk EG003
Insomnia	Psychiatric disorders	26.1	Systematic Assessment	EG0008 affected127 at risk EG00125 affected135 at risk EG0028 affected123 at risk EG003
Breast pain	Reproductive system and breast disorders	26.1	Systematic Assessment	EG0004 affected127 at risk EG00113 affected135 at risk EG0026 affected123 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG00013 affected127 at risk EG00129 affected135 at risk EG0029 affected123 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0004 affected127 at risk EG0019 affected135 at risk EG0029 affected123 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG00011 affected127 at risk EG0019 affected135 at risk EG0028 affected123 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG0017 affected135 at risk EG0024 affected123 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG0017 affected135 at risk EG0024 affected123 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG00083 affected127 at risk EG00164 affected135 at risk EG00280 affected123 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG0017 affected135 at risk EG0023 affected123 at risk EG003
Nail disorder	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG00110 affected135 at risk EG00210 affected123 at risk EG003
Onycholysis	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG0015 affected135 at risk EG0021 affected123 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG00012 affected127 at risk EG00122 affected135 at risk EG0025 affected123 at risk EG003
Rash	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG00018 affected127 at risk EG00130 affected135 at risk EG00216 affected123 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0003 affected127 at risk EG0015 affected135 at risk EG0021 affected123 at risk EG003
Flushing	Vascular disorders	26.1	Systematic Assessment	EG0000 affected127 at risk EG0017 affected135 at risk EG0023 affected123 at risk EG003
Hot flush	Vascular disorders	26.1	Systematic Assessment	EG0009 affected127 at risk EG00133 affected135 at risk EG00212 affected123 at risk EG003
Hypertension	Vascular disorders	26.1	Systematic Assessment	EG00011 affected127 at risk EG0019 affected135 at risk EG0025 affected123 at risk EG003
Lymphoedema	Vascular disorders	26.1	Systematic Assessment	EG0002 affected127 at risk EG0015 affected135 at risk EG0022 affected123 at risk EG003

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D000077594	Nivolumab
D017239	Paclitaxel
D018943	Anthracyclines
D003520	Cyclophosphamide
D013514	Surgical Procedures, Operative

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
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D063088	Phosphoramides
D009943	Organophosphorus Compounds

ID	Title	Description
BG000	Arm A	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Nivolumab 480 mg Q4W + Endocrine Therapy (ET)
BG001	Arm B	Neoadjuvant (Pre-surgery) Phase 8 cycles maximum: Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW Followed by: Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W): Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum: Adjuvant Cycles 1-7 (1 cycle = Q4W): Endocrine Therapy (ET)
BG002	Total	Total of all reporting groups