Study of Durvalumab With Chemoradiotherapy for Women With... | NCT03830866

NCT03830866

ID	Type	Description	Link
2018-002872-42	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Durvalumab (intravenous infusion)	Experimental	durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization	Biological: Durvalumab Drug: Cisplatin Drug: Carboplatin Radiation: external beam radiation therapy (EBRT) + brachytherapy
Placebo (matching placebo for intravenous infusion)	Placebo Comparator	placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)	Drug: Cisplatin Drug: Carboplatin Radiation: external beam radiation therapy (EBRT) + brachytherapy

Name	Type	Description	Arm Group Labels	Other Names
Durvalumab	Biological	IV infusion every 4 weeks	Durvalumab (intravenous infusion)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression	PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression	Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression >= 1%	PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Urban Scheuring, M.D., Ph.D.	AstraZeneca	Study Director
Bradley Monk, M.D	University of Arizona, Arizona, USA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Phoenix	Arizona	85016	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38039991	Derived	Monk BJ, Toita T, Wu X, Vazquez Limon JC, Tarnawski R, Mandai M, Shapira-Frommer R, Mahantshetty U, Del Pilar Estevez-Diz M, Zhou Q, Limaye S, Godinez FJR, Oppermann Kussler C, Varga S, Valdiviezo N, Aoki D, Leiva M, Lee JY, Sulay R, Kreynina Y, Cheng WF, Rey F, Rong Y, Ke G, Wildsmith S, Lloyd A, Dry H, Tablante Nunes A, Mayadev J. Durvalumab versus placebo with chemoradiotherapy for locally advanced cervical cancer (CALLA): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Dec;24(12):1334-1348. doi: 10.1016/S1470-2045(23)00479-5.
32447296

Label	URL
CSR synopsis	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Durvalumab + SoC CCRT	Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
FG001	Placebo + SoC CCRT

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 11, 2021	Jan 13, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Durvalumab + SoC CCRT	Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
BG001	Placebo + SoC CCRT	Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
BG002	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
	BG00049.6± 11.74 BG00148.8± 11.67 BG00249.2± 11.70

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000385 BG001385 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000130 BG001125 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

Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression

PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression

Full Analysis Set

Posted

Median

95% Confidence Interval

Months

Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months

ID	Title	Description
OG000	Durvalumab + SoC CCRT	Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
OG001	Placebo + SoC CCRT	Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)

Units	Counts
Participants	OG000385 OG001385

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)NA - Not calculated, estimates cannot be calculated due to too few events OG001NA(NA to NA)NA - Not calculated, estimates cannot be calculated due to too few events

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		0.174		Hazard Ratio (HR)	0.84			2-Sided	95	0.65	1.08					Superiority

Secondary

Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression >= 1%

PD-L1 Analysis Set

Posted

Median

95% Confidence Interval

Months

ID	Title	Description
OG000	Durvalumab + SoC CCRT	Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
OG001	Placebo + SoC CCRT	Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)

Units	Counts

Secondary

Overall Survival (Count)

Number of Participants with Overall Survival (OS) where OS was defined as the time from the date of randomisation until death by any cause

Full Analysis Set

Posted

Count of Participants

Participants

Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 months

ID	Title	Description
OG000	Durvalumab + SoC CCRT	Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
OG001	Placebo + SoC CCRT	Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)

Units	Counts
Participants	OG000

Secondary

Overall Survival (Duration)

Time from the date of randomisation until death by any cause

Full Analysis Set

Posted

Median

95% Confidence Interval

Months

Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 months

ID	Title	Description
OG000	Durvalumab + SoC CCRT	Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
OG001	Placebo + SoC CCRT	Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)

Units	Counts
Participants	OG000

Secondary

Objective Response Rate (ORR)

Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion

Full analysis set

Posted

Number

Percentage of Participants

ID	Title	Description
OG000	Durvalumab + SoC CCRT	Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
OG001	Placebo + SoC CCRT	Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)

Units	Counts

Secondary

Complete Response Rate

Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)

Full analysis set

Posted

Number

Percentage of Participants

ID	Title	Description
OG000	Durvalumab + SoC CCRT	Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
OG001	Placebo + SoC CCRT	Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)

Units	Counts
Participants

Secondary

Duration of Response (DoR) in Patients With Complete Response (CR)

Time from date of first documented CR until date of documented progression or death in the absence of progression. For patients who did not progress their DoR was their Progression-free survival censoring time

Full Analysis Set

Posted

Median

Inter-Quartile Range

Months

ID	Title	Description
OG000	Durvalumab + SoC CCRT	Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
OG001	Placebo + SoC CCRT	Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Durva + SoC CCRT	Description (Arm-group)	91	385	113	385	373	385
EG001	Placebo + SoC CCRT	Description (Arm-group)	112	385	90	384	368	384

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0012 events2 affected384 at risk
C-reactive protein increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Electrocardiogram q wave abnormal	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Full blood count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Neutrophil count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0012 events2 affected384 at risk
Platelet count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected385 at risk EG0014 events3 affected384 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
White blood cell count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0014 events4 affected384 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected385 at risk EG0010 events0 affected384 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0012 events2 affected384 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Inflammatory pseudotumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0012 events1 affected384 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Cerebral infarction	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Seizure	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Acute psychosis	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Anxiety	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Endocrine disorder	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected385 at risk EG0013 events3 affected384 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0005 events2 affected385 at risk EG0010 events0 affected384 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected385 at risk EG0011 events1 affected384 at risk
Renal failure	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Ureteric fistula	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected385 at risk EG0010 events0 affected384 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Urogenital fistula	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Cervix haemorrhage uterine	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected385 at risk EG0012 events2 affected384 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Vaginal fistula	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0008 events7 affected385 at risk EG0015 events5 affected384 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected385 at risk EG0014 events4 affected384 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Accelerated hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Embolism	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Cataract	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0012 events2 affected384 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00020 events20 affected385 at risk EG00120 events20 affected384 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0007 events6 affected385 at risk EG0012 events2 affected384 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Anorectal disorder	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected385 at risk EG0011 events1 affected384 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected385 at risk EG0012 events2 affected384 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Enteritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0012 events2 affected384 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Ileus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected385 at risk EG0011 events1 affected384 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0005 events5 affected385 at risk EG0011 events1 affected384 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Proctitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected385 at risk EG0011 events1 affected384 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Rectal perforation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Rectal ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0012 events2 affected384 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected385 at risk EG0010 events0 affected384 at risk
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected385 at risk EG0010 events0 affected384 at risk
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Generalised oedema	General disorders	MedDRA 24.1	Systematic Assessment	EG0002 events1 affected385 at risk EG0010 events0 affected384 at risk
Immune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Oedema	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Oedema peripheral	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0004 events3 affected385 at risk EG0011 events1 affected384 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Abdominal infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Appendicitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Atypical pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Covid-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected385 at risk EG0011 events1 affected384 at risk
Cellulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Cystitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Device related infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Endometritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Gastroenteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0011 events1 affected384 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0012 events1 affected384 at risk
Gingivitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Haemophilus infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Hepatitis c	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Herpes zoster	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Infected lymphocele	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Pelvic infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Peritonitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0014 events4 affected384 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Pyelonephritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0012 events2 affected384 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0012 events2 affected384 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0004 events3 affected385 at risk EG0012 events2 affected384 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Salpingitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Sepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected385 at risk EG0011 events1 affected384 at risk
Tubo-ovarian abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Ureteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00019 events16 affected385 at risk EG00115 events11 affected384 at risk
Uterine infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Wound abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0014 events4 affected384 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0012 events2 affected384 at risk
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected385 at risk EG0011 events1 affected384 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Post procedural inflammation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected385 at risk EG0012 events2 affected384 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0010 events0 affected384 at risk
Uterine perforation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected385 at risk EG0012 events2 affected384 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected385 at risk EG0011 events1 affected384 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Aspartate aminotransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00056 events34 affected385 at risk EG00138 events30 affected384 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00030 events21 affected385 at risk EG00117 events13 affected384 at risk
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00048 events31 affected385 at risk EG00130 events23 affected384 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00041 events30 affected385 at risk EG00137 events28 affected384 at risk
Lymphocyte count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG00029 events18 affected385 at risk EG00147 events34 affected384 at risk
Neutrophil count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG000216 events74 affected385 at risk EG001221 events85 affected384 at risk
Platelet count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG00081 events48 affected385 at risk EG001107 events62 affected384 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00046 events38 affected385 at risk EG00138 events28 affected384 at risk
Weight decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG00046 events43 affected385 at risk EG00153 events42 affected384 at risk
White blood cell count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG000296 events71 affected385 at risk EG001340 events85 affected384 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG000103 events89 affected385 at risk EG00174 events64 affected384 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00028 events26 affected385 at risk EG00123 events19 affected384 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00032 events24 affected385 at risk EG00134 events25 affected384 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00063 events44 affected385 at risk EG00174 events46 affected384 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00052 events40 affected385 at risk EG00161 events38 affected384 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00040 events29 affected385 at risk EG00129 events23 affected384 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00051 events44 affected385 at risk EG00149 events42 affected384 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00047 events40 affected385 at risk EG00145 events43 affected384 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG00029 events26 affected385 at risk EG00118 events14 affected384 at risk
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00024 events19 affected385 at risk EG00125 events20 affected384 at risk
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG00055 events42 affected385 at risk EG00151 events43 affected384 at risk
Insomnia	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG00047 events41 affected385 at risk EG00134 events33 affected384 at risk
Dysuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG00074 events61 affected385 at risk EG00180 events70 affected384 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG00027 events26 affected385 at risk EG00113 events12 affected384 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG00048 events40 affected385 at risk EG00141 events37 affected384 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG00037 events30 affected385 at risk EG00131 events28 affected384 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG00028 events24 affected385 at risk EG00133 events29 affected384 at risk
Hypothyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG00068 events60 affected385 at risk EG00121 events21 affected384 at risk
Hot flush	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00031 events28 affected385 at risk EG00124 events21 affected384 at risk
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG00025 events16 affected385 at risk EG00131 events24 affected384 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00021 events20 affected385 at risk EG00113 events11 affected384 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG000315 events209 affected385 at risk EG001322 events200 affected384 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00071 events50 affected385 at risk EG00168 events54 affected384 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00031 events30 affected385 at risk EG00123 events20 affected384 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG000119 events97 affected385 at risk EG001106 events87 affected384 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG000257 events177 affected385 at risk EG001289 events190 affected384 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG00014 events14 affected385 at risk EG00124 events23 affected384 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG000289 events213 affected385 at risk EG001293 events202 affected384 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG000194 events105 affected385 at risk EG001202 events107 affected384 at risk
Asthenia	General disorders	MedDRA 24.1	Systematic Assessment	EG00045 events34 affected385 at risk EG00143 events35 affected384 at risk
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG00055 events52 affected385 at risk EG00179 events70 affected384 at risk
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG00051 events35 affected385 at risk EG00137 events32 affected384 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG000100 events59 affected385 at risk EG001120 events58 affected384 at risk
Covid-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00029 events29 affected385 at risk EG00146 events40 affected384 at risk
Cystitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00028 events25 affected385 at risk EG00121 events19 affected384 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG00059 events39 affected385 at risk EG00151 events29 affected384 at risk
Herpes zoster	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00024 events22 affected385 at risk EG0015 events4 affected384 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG00027 events26 affected385 at risk EG00119 events14 affected384 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG000123 events90 affected385 at risk EG001124 events92 affected384 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG000120 events74 affected385 at risk EG001100 events55 affected384 at risk
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG00021 events20 affected385 at risk EG00110 events10 affected384 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG00027 events25 affected385 at risk EG00126 events26 affected384 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG00018 events17 affected385 at risk EG00127 events27 affected384 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00064 events43 affected385 at risk EG00148 events37 affected384 at risk

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D011878	Radiotherapy
D013812	Therapeutics

ID	Term
C000613593	durvalumab
D002945	Cisplatin
D016190	Carboplatin
D001918	Brachytherapy