Study of the Efficacy and Safety of Ponsegromab in Patien... | NCT05546476

ID	Type	Description	Link
PROACC-1	Other Identifier	Alias Study Number
2023-510446-24-00	Registry Identifier	CTIS (EU)

Study of the Efficacy and Safety of Ponsegromab in Patien... | NCT05546476 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment	Experimental	ponsegromab low dose subcutaneous injection every 4 weeks	Drug: ponsegromab
Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment	Placebo Comparator	Match placebo subcutaneous injection every 4 weeks	Drug: Placebo for ponsegromab
Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment	Experimental	ponsegromab medium dose subcutaneous injection every 4 weeks	Drug: ponsegromab
Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment	Experimental	ponsegromab high dose subcutaneous injection every 4 weeks	Drug: ponsegromab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ponsegromab	Drug	Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment	Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A: Change From Baseline in Body Weight at Week 12	Body weight was measured in kilograms using a calibrated weighing scale. Baseline was defined as the last average of the duplicate measurements prior to, or on Day 1. The average of the duplicate body weights collected at assessment time was considered. The posterior medians and 90 percent (%) credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for each randomized dose (including placebo). 4-Parameter maximal effect (E max) model: change from baseline = E 0 + (E max * dose^Hill) / (ED 50^Hill + dose^Hill), where E0 is the placebo effect, E max is the maximum effect, ED 50 is the dose producing 50% of the maximum effect, and Hill is the slope parameter. Model utilized a Bayesian methodology with a robustified, informative meta-analytic predictive prior for the placebo change from baseline at week 12.	Baseline, Week 12

Secondary Outcomes

Measure	Description	Time Frame
Part A: Change From Baseline in Physical Activity at Week 12	Physical activity was monitored using accelerometry (wearable digital sensors). Physical activity was categorized as: sedentary activity, non-sedentary physical activity, and moderate to vigorous physical activity. In this outcome measure time for each type of physical activity per day was considered. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using mixed models repeated measures (MMRM) model.

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CARTI Conway		Conway	Arkansas	72034	United States
CARTI Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39282907	Derived	Groarke JD, Crawford J, Collins SM, Lubaczewski S, Roeland EJ, Naito T, Hendifar AE, Fallon M, Takayama K, Asmis T, Dunne RF, Karahanoglu I, Northcott CA, Harrington MA, Rossulek M, Qiu R, Saxena AR. Ponsegromab for the Treatment of Cancer Cachexia. N Engl J Med. 2024 Dec 19;391(24):2291-2303. doi: 10.1056/NEJMoa2409515. Epub 2024 Sep 14.
38500292

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Placebo/ Part B: Ponsegromab 400 mg	Part A: Participants were randomized to receive placebo matching to Ponsegromab subcutaneously (SC) once in every 4 weeks (Q4W) up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 2, 2023	Mar 11, 2025

Type	Comment	Reasons
Adverse Event		FG0002 subjects FG0010 subjects FG0020 subjects FG0031 subjects
Death		FG0004 subjects FG0014 subjects FG0025 subjects FG0036 subjects
Lack of Efficacy		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects
Lost to Follow-up		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects
Physician Decision		FG0001 subjects FG0010 subjects FG0020 subjects FG0030 subjects
Progressive disease		FG0003 subjects FG0015 subjects FG0020 subjects FG0031 subjects
Withdrawal by Subject		FG0001 subjects FG0011 subjects FG0021 subjects FG0032 subjects
Global deterioration of health status		FG0002 subjects FG0012 subjects FG0021 subjects FG0034 subjects
Other		FG0000 subjects FG0012 subjects FG0020 subjects FG0030 subjects

Period 2: Part B

Type	Comment	Milestone Data
STARTED		FG00026 subjects FG00127 subjects FG00235 subjects FG00329 subjects
COMPLETED		FG0006 subjects FG0019 subjects FG00211 subjects FG00311 subjects
NOT COMPLETED		FG00020 subjects FG00118 subjects FG00224 subjects FG00318 subjects

Type	Comment	Reasons
Death		FG0006 subjects FG0014 subjects FG0026 subjects FG003

Arm/Group Information

ID	Title	Description
BG000	Part A: Placebo/ Part B: Ponsegromab 400 mg	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
BG001	Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
BG002	Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg	Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
BG003	Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg	Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses). Part B: On completion of Part A, participants had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00063.2± 11.26 BG00170.1± 9.38 BG00265.9± 9.61 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00017 BG00119 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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

Part A: Change From Baseline in Body Weight at Week 12

Body weight was measured in kilograms using a calibrated weighing scale. Baseline was defined as the last average of the duplicate measurements prior to, or on Day 1. The average of the duplicate body weights collected at assessment time was considered. The posterior medians and 90 percent (%) credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for each randomized dose (including placebo). 4-Parameter maximal effect (E max) model: change from baseline = E 0 + (E max * dose^Hill) / (ED 50^Hill + dose^Hill), where E0 is the placebo effect, E max is the maximum effect, ED 50 is the dose producing 50% of the maximum effect, and Hill is the slope parameter. Model utilized a Bayesian methodology with a robustified, informative meta-analytic predictive prior for the placebo change from baseline at week 12.

Censored analysis set included all evaluable participants. For participants who discontinued study intervention, or received a prohibited procedure or prohibited medication, all observations post-discontinuation, or post-procedure, were censored and treated as missing data. For participants who missed a dose, or received an incomplete dose, all observations post-missed/incomplete dose were censored and treated as missing data.

Posted

Median

90% Confidence Interval

Kilogram

Baseline, Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
OG002	Part A: Ponsegromab 200 mg	Part A: Participants were randomized to receive Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).
OG003	Part A: Ponsegromab 400 mg	Part A: Participants were randomized to receive Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).

Units	Counts
Participants	OG00045 OG00146 OG00246 OG003

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)Measure Type = Posterior Median = -0.60 Measure of Dispersion = 90% Credible Interval = -1.50 to 0.24 OG001NA(NA to NA)Measure Type = Posterior Median = 0.75 Measure of Dispersion = 90% Credible Interval = 0.06 to 1.44 OG002

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	Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.					Difference in Posterior Median	1.33			2-Sided	90	0.49	2.34					Superiority
OG000

Secondary

Part A: Change From Baseline in Physical Activity at Week 12

Physical activity was monitored using accelerometry (wearable digital sensors). Physical activity was categorized as: sedentary activity, non-sedentary physical activity, and moderate to vigorous physical activity. In this outcome measure time for each type of physical activity per day was considered. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using mixed models repeated measures (MMRM) model.

Censored analysis set:all evaluable participants.For participants who discontinued study intervention/received prohibited procedure/ prohibited medication,all observations post-discontinuation/post-procedure,were censored and treated as missing data.For participants who missed dose/received incomplete dose,all observations post-missed/incomplete dose were censored and treated as missing data.''Overall Number of Participants Analyzed'' =participants evaluable for this outcome measure at Week 12.

Posted

Least Squares Mean

90% Confidence Interval

Minutes per day

Baseline, Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).

Secondary

Part A: Change From Baseline in Mean Activity Level During Maximum 6 Minutes at Week 12

Physical activity was monitored using accelerometry (wearable digital sensors). In this outcome measure mean activity level during maximum 6 minutes was considered. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.

Posted

Least Squares Mean

90% Confidence Interval

Arbitrary units per day (au/day)

Baseline, Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).

Secondary

Part A: Change From Baseline in Total Vector Magnitude at Week 12

Total vector magnitude is a measure of overall physical activity. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.

Censored analysis set: all evaluable participants. For participants who discontinued study intervention/received prohibited procedure/ prohibited medication,all observations post-discontinuation/post-procedure,were censored and treated as missing data.For participants who missed dose/received incomplete dose,all observations post-missed/incomplete dose were censored and treated as missing data.''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure at Week 12

Posted

Least Squares Mean

90% Confidence Interval

Total activity counts/100 per day

Baseline, Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
OG002	Part A: Ponsegromab 200 mg

Secondary

Part A: Change From Baseline in Gait at Week 12

Gait was monitored using accelerometry (wearable digital sensors). Analysis was performed using MMRM model. Gait included: gait speed and 95th percentile of gait speed. Baseline was defined as the mean taken over the 8 days of wear during screening. Mean taken over the 8 days of wear before Week 12 was considered. Analysis was performed using MMRM model.

Posted

Least Squares Mean

90% Confidence Interval

Meter per second (m/s)

Baseline, Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
OG002

Secondary

Part A: Change From Baseline in Functional Assessment of Anorexia-Cachexia Therapy- Anorexia and Cachexia Subscale (FAACT-ACS) at Week 12

FAACT-ACS is a 12-item symptom-specific subscale to measure participants' concerns about their anorexia (appetite) or cachexia (weight) for past 7 days. Each item was scored from 0 to 4, where 0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, and 4= very much. The total FAACT-ACS score ranged from 0 to 48. Higher scores are associated with a higher health-related quality of life. FAACT-ACS was analyzed using an MMRM model.

Posted

Least Squares Mean

90% Confidence Interval

Units on a scale

Baseline (prior to dose on Day 1), Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).

Secondary

Part A: Change From Baseline in FAACT- 5-Item Anorexia Symptom Scale (5IASS) at Week 12

FAACT-5IASS is a 5-item subscale to measure participants' perceptions of anorexia (appetite) concerns for past 7 days. Each item was scored from 0 to 4, where 0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, and 4= very much. The total FAACT-5IASS score ranged from 0 to 20. Higher scores are associated with a higher health-related quality of life. FAACT-5IASS was analyzed using an MMRM model.

Posted

Least Squares Mean

90% Confidence Interval

Units on a scale

Baseline (prior to dose on Day 1), Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).

Secondary

Part A: Change From Baseline in Cancer-Related Cachexia Symptom Diary (CRCSD) Scores at Week 12: Appetite, Nausea and Physical Fatigue

The CRCSD is a daily, self-reported questionnaire that measured severity of symptoms related to cancer cachexia: appetite, nausea, vomiting, and fatigue. Participants rated appetite, nausea and physical fatigue symptom every day, and weekly averages were calculated over the 7 days prior, from 0 to 10, where 0 = no symptom and 10 = worst possible symptom. Higher scores indicated more severe disease. CRCSD was analyzed using an MMRM model.

Posted

Least Squares Mean

90% Confidence Interval

Units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).

Secondary

Part A: Median Change From Baseline in CRCSD Scores at Week 12: Vomiting Frequency

The CRCSD is a daily, self-reported questionnaire that measured severity of symptoms related to cancer cachexia: vomiting frequency. Participants rated vomiting frequency over the past 24 hours, from 0 to 30, where 0 = no symptom and 30 = worst possible symptom. Higher scores indicated more severe disease.

Posted

Median

Inter-Quartile Range

Units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
OG002	Part A: Ponsegromab 200 mg

Secondary

Part A: Number of Participants With Treatment Emergent Adverse Events (TEAE)

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE were defined as any event that was not present before exposure to study drug, or any event already present that worsened in either intensity or frequency after exposure to study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included serious AEs and all non-SAEs.

Posted

Count of Participants

Participants

From the first dose of study drug until first dose of open-label ponsegromab 400 mg for participants entering Part B or through Week 16 follow-up for participants not entering Part B (including 8 weeks of follow-up from last dose of study drug in part A)

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).

Secondary

Part A: Number of Participants With Incidence of Laboratory Test Abnormalities

Laboratory test abnormality parameters included: hematology- hemoglobin (gram per deciliter [g/dL]), hematocrit (%), erythrocytes (10^12/Liter [L]) less than (<) 0.8*lower limit of normal (LLN); platelets (10^9/L) <0.5*LLN to more than (>) 1.75*upper limit of normal (ULN); leukocytes (10^9/L) <0.6*LLN to >1.5*ULN; lymphocytes, neutrophils (10^9/L) <0.8*LLN to >1.2*ULN. Clinical chemistry- bilirubin, glucose (mg/dL) >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (Units/L [U/L]) >3.0*ULN; protein, albumin (gram [g]/dL) <0.8*LLN; urea (mmol/L) >1.3xULN; creatinine (mg/dL) >1.3*ULN; sodium (milliequivalents [mEq]/L) <0.95*LLN; potassium (mEq/L) <0.9*LLN to >1.1*ULN.

Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Posted

Count of Participants

Participants

Day 1 up to Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).

Secondary

Part A: Number of Participants With Post-Baseline Vital Signs Meeting the Predefined Criteria

Vital signs criteria included: supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg), increase and decrease in change of more than or equal to (>=) 30mmHg; supine diastolic blood pressure (DBP) <50 mmHg, increase and decrease in change of >= 20mmHg; pulse rate <40 beats per minute (bpm) to >120 bpm. Only rows which included at least 1 participant in any reporting group with abnormality were reported in this outcome measure.

Posted

Count of Participants

Participants

Day 1 up to Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
OG002	Part A: Ponsegromab 200 mg

Secondary

Part A: Number of Participants With Clinically Significant Echocardiogram (ECG) Abnormalities

ECG parameters included heart rate (HR), PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF) and QRS complex. HR: RR (interval between 2 successive R waves on ECG) decrease >25% and to a VR (interval between QRS wave and T wave on ECG) >100, RR increase >25% and to a VR <50; PR interval: baseline less than or equal to (<=) 200 and % change >= 50%; QT interval: >450, >480, >500, increase from baseline >30, increase from baseline >60; QTcF: 470 < value <= 480, 480 < value <= 500, value > 500, 30 < change <= 60 and change >60; QRS complex: value >= 140, % change >=50%. Clinically significant values were determined by the investigator.

Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Posted

Count of Participants

Participants

Day 1 up to Week 12

ID	Title	Description
OG000	Part A: Placebo	Part A: Participants were randomized to receive placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
OG001	Part A: Ponsegromab 100 mg	Part A: Participants were randomized to receive Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
OG002	Part A: Ponsegromab 200 mg

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	Part A: Placebo	Participants received placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).	5	45	11	45	26	45
EG001	Part A: Ponsegromab 100 mg	Participants received Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).	6	46	15	46	22	46
EG002	Part A: Ponsegromab 200 mg	Participants received Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).	6	46	10	46	19	46
EG003	Part A: Ponsegromab 400 mg	Participants received Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).	9	50	20	50	24	50
EG004	Part A: Placebo/ Part B: Ponsegromab 400 mg	Participants who received placebo had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.	8	24	9	24	16	24
EG005	Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg	Participants who received Ponsegromab 100 mg had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.	10	27	14	27	22	27
EG006	Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg	Participants who received Ponsegromab 200 mg had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.	13	34	16	34	24	34
EG007	Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg	Participants who received Ponsegromab 400 mg had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.	5	29	11	29	19	29

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG0030 affected50 at risk EG0040 affected24 at risk EG0050 affected27 at risk EG0060 affected34 at risk EG0070 affected29 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Tachycardia	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0012 affected46 at risk EG0020 affected46 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Anal incontinence	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Rectal obstruction	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
Asthenia	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Fatigue	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
General physical health deterioration	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Inflammation	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Malaise	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Oedema peripheral	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Pain	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Pyrexia	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Biliary tract infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
COVID-19	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Herpes zoster	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Infectious pleural effusion	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Influenza	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Intestinal fistula infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Pneumonia	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0011 affected46 at risk EG0022 affected46 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Sepsis	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Septic shock	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Anastomotic complication	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0011 affected46 at risk EG0023 affected46 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Non-systematic Assessment	EG0002 affected45 at risk EG0012 affected46 at risk EG0022 affected46 at risk EG003
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Cerebral amyloid angiopathy	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Diplegia	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Normal pressure hydrocephalus	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Paraplegia	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hypotension	Vascular disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0005 affected45 at risk EG0015 affected46 at risk EG0025 affected46 at risk EG0034 affected50 at risk EG0044 affected24 at risk EG0056 affected27 at risk EG0063 affected34 at risk EG0071 affected29 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0003 affected45 at risk EG0013 affected46 at risk EG0021 affected46 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0013 affected46 at risk EG0020 affected46 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0004 affected45 at risk EG0013 affected46 at risk EG0022 affected46 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0008 affected45 at risk EG0013 affected46 at risk EG0024 affected46 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0007 affected45 at risk EG0011 affected46 at risk EG0021 affected46 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0005 affected45 at risk EG0012 affected46 at risk EG0022 affected46 at risk EG003
Asthenia	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0011 affected46 at risk EG0023 affected46 at risk EG003
Fatigue	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0002 affected45 at risk EG0011 affected46 at risk EG0021 affected46 at risk EG003
Oedema	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Oedema peripheral	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected45 at risk EG0011 affected46 at risk EG0020 affected46 at risk EG003
Pyrexia	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0003 affected45 at risk EG0010 affected46 at risk EG0025 affected46 at risk EG003
COVID-19	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Pneumonia	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0003 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0003 affected45 at risk EG0010 affected46 at risk EG0022 affected46 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0012 affected46 at risk EG0020 affected46 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0003 affected45 at risk EG0010 affected46 at risk EG0021 affected46 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
White blood cell count decreased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0014 affected46 at risk EG0021 affected46 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0003 affected45 at risk EG0014 affected46 at risk EG0021 affected46 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0004 affected45 at risk EG0016 affected46 at risk EG0020 affected46 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Headache	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0011 affected46 at risk EG0023 affected46 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0002 affected45 at risk EG0011 affected46 at risk EG0021 affected46 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Hypertension	Vascular disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Weight decreased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Dizziness	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Delirium	Psychiatric disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected45 at risk EG0010 affected46 at risk EG0020 affected46 at risk EG003

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004067	Digestive System Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001836	Body Weight Changes
D001835	Body Weight
D013851	Thinness

Title

Denominators

Categories

Time for Sedentary Activity

Title	Measurements
	OG000-1.42(-72.77 to 69.92) OG00151.93(-9.88 to 113.75) OG002-39.33(-101.94 to 23.29) OG003-3.37(-72.89 to 66.14)

Time for Non-Sedentary Physical Activity

Title	Measurements
	OG000-37.73(-66.14 to -9.32) OG0010.03(-24.88 to 24.95) OG002-42.09(-67.63 to -16.56) OG003

Time for Moderate to Vigorous Physical Activity

Title	Measurements
	OG000-4.45(-13.91 to 5.02) OG0014.07(-4.18 to 12.32) OG0020.05(-8.29 to 8.39) OG003

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.8260	Difference in LS Mean	53.36	2-Sided	90	-40.89	147.60	Superiority
OG000 OG002	Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.2540	Difference in LS Mean	-37.9	2-Sided	90	-132.94	57.14	Superiority
OG000 OG003	Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.4870	Difference in LS Mean	-1.95	2-Sided	90	-101.63	97.73	Superiority
OG000 OG001	Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.0497	Difference in LS Mean	37.76	2-Sided	90	0.07	75.46	Superiority
OG000 OG002	Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.5745	Difference in LS Mean	-4.36	2-Sided	90	-42.94	34.22	Superiority
OG000 OG003	Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.0189	Difference in LS Mean	49.85	2-Sided	90	10.62	89.08	Superiority
OG000 OG001	Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.1302	Difference in LS Mean	8.51	2-Sided	90	-4.00	21.03	Superiority
OG000 OG002	Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.2780	Difference in LS Mean	4.49	2-Sided	90	-8.18	17.16	Superiority
OG000 OG003	Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.1529	Difference in LS Mean	8.11	2-Sided	90	-5.01	21.23	Superiority

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.5762	Difference in LS Mean	-130.27	2-Sided	90	-1257.31	996.77	Superiority
OG000 OG002	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.1486	Difference in LS Mean	724.14	2-Sided	90	-425.81	1874.09	Superiority
OG000 OG003	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.3972	Difference in LS Mean	185.62	2-Sided	90	-997.94	1369.18	Superiority

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.0985	Difference in LS Mean	1587.26	2-Sided	90	-443.79	3618.31	Superiority
OG000 OG002	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.5315	Difference in LS Mean	-98.54	2-Sided	90	-2169.67	1972.58	Superiority
OG000 OG003	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.0437	Difference in LS Mean	2203.18	2-Sided	90	84.51	4321.85	Superiority

Title

Denominators

Categories

Gait Speed

Title	Measurements
	OG000-0.008(-0.042 to 0.026) OG001-0.009(-0.040 to 0.023) OG002-0.012(-0.044 to 0.019) OG0030.009(-0.024 to 0.042)

95th percentile of gait speed

Title	Measurements
	OG0000.011(-0.041 to 0.064) OG0010.011(-0.037 to 0.059) OG002-0.015(-0.063 to 0.033) OG003

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.5052	Difference in LS Mean	0	2-Sided	90	-0.046	0.045	Superiority
OG000 OG002	Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.5599	Difference in LS Mean	-0.004	2-Sided	90	-0.050	0.042	Superiority
OG000 OG003	Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.2770	Difference in LS Mean	0.017	2-Sided	90	-0.030	0.064	Superiority
OG000 OG001	95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.5047	Difference in LS Mean	0	2-Sided	90	-0.071	0.070	Superiority
OG000 OG002	95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.7316	Difference in LS Mean	-0.026	2-Sided	90	-0.097	0.045	Superiority
OG000 OG003	95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.4145	Difference in LS Mean	0.01	2-Sided	90	-0.063	0.082	Superiority

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.0114	Difference in LS Mean	4.24	2-Sided	90	1.19	7.28	Superiority
OG000 OG002	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.3600	Difference in LS Mean	0.64	2-Sided	90	-2.30	3.57	Superiority
OG000 OG003	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.0138	Difference in LS Mean	4.11	2-Sided	90	1.06	7.17	Superiority

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.0090	Difference in LS Mean	2.35	2-Sided	90	0.72	3.97	Superiority
OG000 OG002	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.4987	Difference in LS Mean	0	2-Sided	90	-1.55	1.56	Superiority
OG000 OG003	MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.0100	Difference in LS Mean	2.3	2-Sided	90	0.68	3.92	Superiority

Title

Denominators

Categories

Appetite

Title	Measurements
	OG000-0.23(-0.83 to 0.37) OG0010.20(-0.36 to 0.76) OG0020.23(-0.37 to 0.82) OG0030.69(0.11 to 1.27)

Nausea

Title	Measurements
	OG000-0.33(-0.82 to 0.17) OG0010.14(-0.32 to 0.61) OG0020.06(-0.43 to 0.55) OG003

Physical Fatigue

Title	Measurements
	OG000-0.27(-0.85 to 0.32) OG0010.39(-0.16 to 0.94) OG0020.38(-0.21 to 0.96) OG003

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type
OG000 OG001	Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.1912	Difference in LS Mean	0.43	2-Sided	90	-0.38	1.24	Superiority
OG000 OG002	Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.1866	Difference in LS Mean	0.46	2-Sided	90	-0.39	1.30	Superiority
OG000 OG003	Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.0349	Difference in LS Mean	0.92	2-Sided	90	0.09	1.75	Superiority
OG000 OG001	Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.8754	Difference in LS Mean	0.47	2-Sided	90	-0.20	1.14	Superiority
OG000 OG002	Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.8205	Difference in LS Mean	0.38	2-Sided	90	-0.31	1.08	Superiority
OG000 OG003	Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.3375	Difference in LS Mean	-0.17	2-Sided	90	-0.86	0.51	Superiority
OG000 OG001	Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.9138	Difference in LS Mean	0.66	2-Sided	90	-0.14	1.45	Superiority
OG000 OG002	Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.9011	Difference in LS Mean	0.64	2-Sided	90	-0.18	1.46	Superiority
OG000 OG003	Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy [platinum or not at randomization +/- 28 days], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.	MMRM analysis; 1-sided	=0.6618	Difference in LS Mean	0.21	2-Sided	90	-0.61	1.02	Superiority

Title

Denominators

Categories

Supine SBP Value < 90mmHg

Title	Measurements
	OG0000 OG0013 OG0020 OG0030

Supine SBP Increase Change >= 30mmHg

Title	Measurements
	OG0004 OG0015 OG0028 OG003

Supine SBP Decrease Change >= 30mmHg

Title	Measurements
	OG0002 OG0016 OG0025 OG003

Supine DBP Value < 50mmHg

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Supine SBP Increase Change >= 20mmHg

Title	Measurements
	OG0004 OG0014 OG0023 OG003

Supine DBP Decrease Change >= 20mmHg

Title	Measurements
	OG0003 OG0014 OG0024 OG003

Supine Pulse Rate Value > 120mmHg

Title	Measurements
	OG0000 OG0011 OG0023 OG003

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D010190	Pancreatic Neoplasms
D015179	Colorectal Neoplasms
D000855	Anorexia
D005221	Fatigue
D002100	Cachexia
D009369	Neoplasms
D015431	Weight Loss