Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Pl... | NCT03834506

ID	Type	Description
MK-3475-921	Other Identifier	MSD
KEYNOTE-921	Other Identifier	MSD
JAPAC-CTI	Registry Identifier	194831
2018-004116-22	EudraCT Number

Label	Type	Description	Intervention Names
Pembrolizumab+Docetaxel	Experimental	Participants receive pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.	Biological: Pembrolizumab Drug: Docetaxel Drug: Prednisone Drug: Dexamethasone
Placebo+Docetaxel	Placebo Comparator	Participants receive placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.	Drug: Docetaxel Drug: Prednisone Drug: Placebo Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	IV infusion	Pembrolizumab+Docetaxel	MK-3475

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit Kaplan-Meier (K-M) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.	Up to 36.5 months
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Radiological progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit K-M method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.	Up to approximately 28 months

Measure	Description	Time Frame
Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)	TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit K-M method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama, Mitchell Cancer Institute ( Site 0065)		Mobile	Alabama	36604	United States

PubMed Identifier	Type	Citation	Retractions
40043230	Result	Petrylak DP, Ratta R, Matsubara N, Korbenfeld E, Gafanov R, Mourey L, Todenhofer T, Gurney H, Kramer G, Bergman AM, Zalewski P, De Santis M, Armstrong AJ, Gerritsen W, Pachynski R, Byun SS, Retz M, Levesque E, McDermott R, Bracarda S, Manneh R, Levartovsky M, Li XT, Schloss C, Poehlein CH, Fizazi K. Pembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial. J Clin Oncol. 2025 May 10;43(14):1638-1649. doi: 10.1200/JCO-24-01283. Epub 2025 Mar 5.
34098744

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

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	Sep 29, 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

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit Kaplan-Meier (K-M) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.

All randomized participants in the intent to treat population who had data available for analysis

Posted

Median

95% Confidence Interval

Months

Up to 36.5 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
OG001	Placebo + Docetaxel	Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Units	Counts
Participants	OG000515 OG001515

Title

Denominators

Categories

Title	Measurements
	OG00019.6(18.2 to 20.9) OG00119.0(17.9 to 20.9)

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		Log Rank		0.1677	One-sided p-value based on log-rank test stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.	Hazard Ratio (HR)	0.92			2-Sided	95	0.78	1.09			HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.		Superiority

Primary

Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Radiological progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit K-M method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.

All randomized participants in the intent to treat population who had data available for analysis

Posted

Median

95% Confidence Interval

Months

Up to approximately 28 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Secondary

Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)

TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit K-M method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received.

All randomized participants in the intent to treat population who had data available for analysis

Posted

Median

95% Confidence Interval

Months

Up to approximately 28 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
OG001	Placebo + Docetaxel	Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Secondary

Prostate-specific Antigen (PSA) Response Rate

The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements.

All randomized participants in the intent to treat population, who had a PSA measurement at baseline, and had data available for analysis

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 36.5 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
OG001	Placebo + Docetaxel	Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Secondary

Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

ORR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).

All randomized participants in the intent to treat population, with measurable disease at baseline, and had data available for analysis

Posted

Number

95% Confidence Interval

Percentage of participants

Up to 36.5 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
OG001	Placebo + Docetaxel

Secondary

Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

DOR was the time from first documented evidence of complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease [NED] on bone scan per PCWG) or partial response (PR: ≥30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG) until progressive disease (PD) or death. PD per RECIST 1.1 was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare and were persistent for ≥6 weeks. The DOR was calculated using the product-limit K-M method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.

All randomized participants in the intent to treat population, who demonstrated a CR or PR, and had data available for analysis

Posted

Median

95% Confidence Interval

Months

Up to 36.5 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Secondary

Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm (AQA) Score

TTPP was the time from randomization to pain progression (PP) based on BPI-SF Item 3 and AQA score. BPI-SF assesses pain intensity; for item 3, participant responses to "Please rate your pain at its worst in the last 24 hours" are scored from 0 (no pain) to 10 (worst pain). A higher score indicates greater pain. AQA captures the intensity of analgesic use in pain management, scored from 0 (no analgesic) to 7 (strong opioid use). A higher score indicates higher intensity of analgesic use.

For participants asymptomatic at baseline, PP was ≥2-point change from baseline in BPI-SF item 3 score OR initiation of opioid use. For participants symptomatic at baseline, PP was ≥2-point change from baseline in the BPI-SF Item 3 score, a score of ≥4 and no decrease in average opioid use OR any increase in opioid use (e.g., 1 point change in AQA score). TTPP was assessed by product-limit K-M method. Participants with >2 consecutive unevaluable visits were censored at the last evaluable assessment.

All participants in the patient-reported outcomes (PRO) full analysis set who received ≥1 dose of study treatment and who had ≥1 PRO assessment available

Posted

Median

95% Confidence Interval

Months

Up to 36.5 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Secondary

Time to First Symptomatic Skeletal-related Event (SSRE)

SSRE was the time from randomization to the first symptomatic skeletal-related event defined as:

Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms
Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral)
Occurrence of spinal cord compression
Tumor-related orthopedic surgical intervention, whichever occurs first.

The SSRE was calculated using the product-limit K-M method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.

All randomized participants in the intent to treat population who had data available for analysis

Posted

Median

95% Confidence Interval

Months

Up to 36.5 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
OG001	Placebo + Docetaxel	Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Secondary

Time to Prostate-specific Antigen (PSA) Progression

The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of:

≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR
≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline

Time to PSA progression was calculated using the product-limit K-M method for censored data. Participants without PSA progression were censored at the last evaluable assessment.

All randomized participants in the intent to treat population, who had a PSA measurement at baseline, and had data available for analysis

Posted

Median

95% Confidence Interval

Months

Up to 36.5 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
OG001	Placebo + Docetaxel	Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Secondary

Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit K-M method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.

All randomized participants in the intent to treat population who had data available for analysis

Posted

Median

95% Confidence Interval

Months

Up to 36.5 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.

All participants who received ≥1 dose of study treatment

Posted

Count of Participants

Participants

Up to approximately 30 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
OG001	Placebo + Docetaxel	Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Secondary

Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)

All participants who received ≥1 dose of study treatment

Posted

Count of Participants

Participants

Up to approximately 27 months

ID	Title	Description
OG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
OG001	Placebo + Docetaxel	Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected514 at risk EG0015 events5 affected514 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00034 events28 affected514 at risk EG00123 events22 affected514 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Necrotic lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00010 events6 affected514 at risk EG0018 events7 affected514 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events2 affected514 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0014 events4 affected514 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected514 at risk EG0010 events0 affected514 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events2 affected514 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Coronary artery disease	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected514 at risk EG0011 events1 affected514 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Pericarditis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Subendocardial ischaemia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events1 affected514 at risk
Hypophysitis	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Blindness unilateral	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Cataract	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Diplopia	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Retinal artery occlusion	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Retinal tear	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected514 at risk EG0010 events0 affected514 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected514 at risk EG0010 events0 affected514 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00013 events13 affected514 at risk EG00110 events9 affected514 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events2 affected514 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Intestinal ulcer	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected514 at risk EG0012 events2 affected514 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Oroantral fistula	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Proctitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events1 affected514 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Chest discomfort	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Complication associated with device	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Death	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0012 events2 affected514 at risk
General physical health deterioration	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0012 events2 affected514 at risk
Inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Mucosal inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected514 at risk EG0014 events4 affected514 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Contrast media allergy	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Abdominal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Abscess limb	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Abscess neck	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Anal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Appendicitis perforated	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Atypical pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Bacterial infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected514 at risk EG0016 events6 affected514 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected514 at risk EG0016 events6 affected514 at risk
Catheter site cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Catheter site infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0013 events3 affected514 at risk
Clostridial sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Cystitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Device related bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Device related infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Device related sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Diverticulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events2 affected514 at risk
Encephalitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Endocarditis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Endophthalmitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Erysipelas	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Escherichia infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events2 affected514 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Herpes zoster meningomyelitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Joint abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Meningitis meningococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Meningoencephalitis herpetic	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Parotitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Peritonitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Pharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Pleural infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00014 events14 affected514 at risk EG00114 events12 affected514 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events2 affected514 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events2 affected514 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected514 at risk EG0012 events2 affected514 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0013 events3 affected514 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected514 at risk EG0012 events2 affected514 at risk
Rhinovirus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0013 events3 affected514 at risk
Septic shock	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Soft tissue infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Spinal cord infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Streptococcal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected514 at risk EG0018 events7 affected514 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Urosepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0014 events4 affected514 at risk
Vascular device infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected514 at risk EG0010 events0 affected514 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0011 events1 affected514 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Pulmonary radiation injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected514 at risk EG0010 events0 affected514 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events2 affected514 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0013 events3 affected514 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Transfusion related complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Blood calcium increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Hepatic enzyme increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Influenza A virus test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Neutrophil count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected514 at risk EG0011 events1 affected514 at risk
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected514 at risk EG0011 events1 affected514 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected514 at risk EG0012 events2 affected514 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected514 at risk EG0011 events1 affected514 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected514 at risk EG0017 events6 affected514 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected514 at risk EG0014 events4 affected514 at risk
Crowned dens syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0013 events3 affected514 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0014 events3 affected514 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected514 at risk EG0011 events1 affected514 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Tumour compression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Cerebellar haematoma	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected514 at risk EG0011 events1 affected514 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Nerve compression	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Radiculopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Spinal cord compression	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0015 events5 affected514 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0011 events1 affected514 at risk
Device occlusion	Product Issues	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Confusional state	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected514 at risk EG0013 events3 affected514 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0009 events8 affected514 at risk EG0015 events4 affected514 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events2 affected514 at risk
Renal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0012 events2 affected514 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0014 events4 affected514 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0010 events0 affected514 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected514 at risk EG0010 events0 affected514 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00015 events15 affected514 at risk EG0016 events6 affected514 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected514 at risk EG0018 events8 affected514 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected514 at risk EG0011 events1 affected514 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Arteriosclerosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Embolism	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0012 events2 affected514 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0012 events1 affected514 at risk
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected514 at risk EG0010 events0 affected514 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected514 at risk EG0011 events1 affected514 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected514 at risk EG0011 events1 affected514 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000177 events147 affected514 at risk EG001168 events126 affected514 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00052 events41 affected514 at risk EG00147 events37 affected514 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG00037 events35 affected514 at risk EG00117 events16 affected514 at risk
Lacrimation increased	Eye disorders	MedDRA 26.1	Systematic Assessment	EG00035 events33 affected514 at risk EG00138 events38 affected514 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00030 events26 affected514 at risk EG00132 events28 affected514 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000152 events110 affected514 at risk EG00199 events85 affected514 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000356 events209 affected514 at risk EG001289 events184 affected514 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000178 events124 affected514 at risk EG001194 events135 affected514 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00043 events34 affected514 at risk EG00130 events29 affected514 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00070 events50 affected514 at risk EG00190 events70 affected514 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG000180 events132 affected514 at risk EG001201 events128 affected514 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG000255 events183 affected514 at risk EG001224 events184 affected514 at risk
Mucosal inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG00031 events26 affected514 at risk EG00134 events31 affected514 at risk
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG000105 events95 affected514 at risk EG001120 events106 affected514 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG00069 events58 affected514 at risk EG00152 events42 affected514 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00048 events36 affected514 at risk EG00138 events33 affected514 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00038 events27 affected514 at risk EG00130 events28 affected514 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00032 events29 affected514 at risk EG00127 events24 affected514 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00028 events28 affected514 at risk EG00126 events25 affected514 at risk
Neutrophil count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG000107 events47 affected514 at risk EG001112 events49 affected514 at risk
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00045 events42 affected514 at risk EG00129 events29 affected514 at risk
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00060 events32 affected514 at risk EG00154 events27 affected514 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG000145 events107 affected514 at risk EG001126 events98 affected514 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00054 events47 affected514 at risk EG00167 events54 affected514 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00037 events27 affected514 at risk EG00120 events15 affected514 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG000125 events86 affected514 at risk EG001122 events99 affected514 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG000105 events91 affected514 at risk EG001117 events101 affected514 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00047 events44 affected514 at risk EG00151 events45 affected514 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00055 events49 affected514 at risk EG00150 events42 affected514 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00047 events40 affected514 at risk EG00157 events46 affected514 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00042 events38 affected514 at risk EG00149 events41 affected514 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00088 events73 affected514 at risk EG00185 events79 affected514 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00049 events38 affected514 at risk EG00139 events34 affected514 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00028 events27 affected514 at risk EG00130 events27 affected514 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG000143 events132 affected514 at risk EG001108 events100 affected514 at risk
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG00051 events43 affected514 at risk EG00146 events46 affected514 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00025 events23 affected514 at risk EG00132 events28 affected514 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00053 events47 affected514 at risk EG00139 events36 affected514 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00066 events61 affected514 at risk EG00163 events59 affected514 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG000185 events182 affected514 at risk EG001198 events193 affected514 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00024 events23 affected514 at risk EG00132 events29 affected514 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00026 events25 affected514 at risk EG00128 events27 affected514 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00030 events30 affected514 at risk EG00130 events30 affected514 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00053 events46 affected514 at risk EG00131 events26 affected514 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00070 events57 affected514 at risk EG00162 events54 affected514 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00031 events28 affected514 at risk EG00132 events29 affected514 at risk

ID	Term
D011471	Prostatic Neoplasms
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
C582435	pembrolizumab
D000077143	Docetaxel
D011241	Prednisone
D000077330	Saline Solution
D003907	Dexamethasone
D002123	Calcium Dobesilate

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D011246	Pregnadienetriols
D013259	Steroids, Fluorinated
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D001190	Arylsulfonates
D017739	Arylsulfonic Acids
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds

ID	Title	Description
BG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
BG001	Placebo + Docetaxel	Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pembrolizumab + Docetaxel	Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.	343	515	212	514	496	514
EG001	Placebo + Docetaxel	Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.	329	515	197	514	488	514