Carboplatin-paclitaxel With Retifanlimab or Placebo in Pa... | NCT04472429

NCT04472429

ID	Type	Description	Link
2024-512331-72-00	Registry Identifier	EU CT Number
2020-000826-24	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A : carboplatin+paclitaxel+placebo	Placebo Comparator	Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle	Drug: carboplatin Drug: paclitaxel
Group B : carboplatin+paclitaxel+retifanlimab	Experimental	Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle	Drug: carboplatin Drug: paclitaxel Drug: retifanlimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
carboplatin	Drug	carboplatin will be administered intravenous on Day 1 of each 28 day cycle	Group A : carboplatin+paclitaxel+placebo Group B : carboplatin+paclitaxel+retifanlimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.	up to 33.9 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival was defined as the time from the date of randomization until the date of death due to any cause.	up to 40.4 months
Objective Response Rate (ORR)	ORR was defined as the percentage of participants with a CR or PR at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to comprehend and willing to sign a written ICF for the study.
- Are 18 years of age or older (or as applicable per local country requirements).
- Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC.
- No prior systemic therapy other than the following: a. Chemotherapy administered concomitantly with radiotherapy as a radiosensitizing agent is permitted.
  
  b. Prior neoadjuvant or adjuvant therapy if completed ≥ 6 months before study entry.
- Has measurable disease per RECIST v1.1 as determined by local site investigator/radiology assessment. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion.
- Able and willing to provide adequate tissue sample and whole blood sample with central testing result prior to randomization. Biopsy for archival samples should have occurred within 9 months prior to randomization.
- ECOG performance status 0 to 1.
- If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 200/μL, b. Undetectable viral load per standard of care assay, c. Receiving antiretroviral therapy (ART/HAART) for at least 4 weeks prior to study enrollment, and have not experienced any HIV-related opportunistic infection for at least 4 weeks prior to study enrollment.
- Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

Has received prior PD-(L)1 directed therapy
Has received prior radiotherapy with or without radiosensitizing chemotherapy within 28 days of Cycle 1 Day 1 except for palliative radiation (30 Gy or less) which is restricted for 14 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to Grade ≤ 1).
Participants with laboratory outside of the protocol defined ranges.
History of second malignancy within 3 years (with exceptions).
Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
Active bacterial, fungal, or viral infections, including hepatitis A, B, and C and IV antibiotic use within 7 days of Cycle 1 Day 1.
Receipt of a live vaccine within 28 days of planned start of study therapy.
History of organ transplant, including allogeneic stem cell transplantation.
Known active CNS metastases and/or carcinomatous meningitis.
Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of the excipients that cannot be controlled with standard measures (eg, antihistamines, corticosteroids).
Participant is pregnant or breastfeeding.
Current use of protocol defined prohibited medication.
Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.
Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements

Facility	Status	City	State	ZIP	Country	Contacts
The University of Arizona Cancer Center		Tucson	Arizona	85724	United States
City of Hope National Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40517007	Derived	Rao S, Samalin-Scalzi E, Evesque L, Ben Abdelghani M, Morano F, Roy A, Dahan L, Tamberi S, Dhadda AS, Saunders MP, Casanova N, Guimbaud R, Lievre A, Maurel J, Fakih M, Tian C, Harrison J, Jones MM, Cornfeld M, Spano JP, Rochefort P; POD1UM-303/InterAACT-2 study investigators. Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial. Lancet. 2025 Jun 14;405(10495):2144-2152. doi: 10.1016/S0140-6736(25)00631-2.
36091159

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).

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	Feb 4, 2025	Apr 8, 2025

Arm/Group Information

ID	Title	Description
BG000	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).
BG001	Placebo + Chemotherapy	Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
BG002	Total	Total of all reporting groups

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)

PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review committee (BICR), or death due to any cause, whichever occurred first. PD: progression of a target or non-target lesion or presence of a new lesion.

Full Analysis Set: all randomized participants. Participants were analyzed according to the treatment and strata they had been assigned during randomization. Median PFS time was estimated using the Kaplan-Meier method. The confidence interval for median PFS time was calculated using the method of Brookmeyer and Crowley.

Posted

Median

95% Confidence Interval

months

up to 33.9 months

ID	Title	Description
OG000	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).
OG001	Placebo + Chemotherapy	Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.

Units	Counts
Participants	OG000154 OG001154

Title

Denominators

Categories

Title	Measurements
	OG0009.3(7.5 to 11.3) OG0017.4(7.1 to 7.7)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		stratified log-rank test		0.0006	tested at the 1-sided 2.5% level	Hazard Ratio (HR)	0.63			2-Sided	95	0.47	0.84			A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.		Superiority

Secondary

Overall Survival

Overall survival was defined as the time from the date of randomization until the date of death due to any cause.

Not Posted

Mar 2028

up to 40.4 months

Participants

Secondary

Objective Response Rate (ORR)

ORR was defined as the percentage of participants with a CR or PR at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Not Posted

Mar 2028

up to 445 days

Participants

Secondary

Duration of Response (DOR)

DOR was defined as the time from the first documented response (CR or PR) determined by BICR to the time of first documented disease progression per RECIST v1.1 or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

Not Posted

Mar 2028

up to 32.1 months

Participants

Secondary

Disease Control Rate (DCR)

DCR was defined as the percentage of participants maintaining either a confirmed overall response of CR or PR or stable disease (SD) at any post-Baseline visit before the first PD or new anticancer therapy, according to RECIST v1.1 as determined by BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.

Not Posted

Mar 2028

up to 445 days

Participants

Secondary

Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) During the Randomized Period

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.

Safety Population: all randomized participants who received at least 1 dose of study treatment. Treatment groups for this population were determined according to the actual treatment the participant received regardless of treatment assignment at randomization.

Posted

Count of Participants

Participants

up to 535 days

ID	Title	Description
OG000	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).

Secondary

Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Randomized Period

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of a pre-existing events after the first dose of study treatment and within 90 days of the last administration of retifanlimab/placebo, or within 30 days of the last chemotherapy. AEs that occurred after new anticancer therapy were be excluded.

Safety Population

Posted

Count of Participants

Participants

up to 535 days

ID	Title	Description
OG000	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).
OG001	Placebo + Chemotherapy

Secondary

Number of Participants With Any TEAE During the Open-label Monotherapy Period

Not Posted

Mar 2028

up 457 days

Participants

Secondary

Number of Participants With Any TEAE Leading to Discontinuation of Study Drug During the Open-label Monotherapy Period

Not Posted

Mar 2028

up 457 days

Participants

Secondary

Cmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel

Cmax was defined as the maximum observed plasma concentration of retifanlimab.

Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study treatment and provided at least 1 postdose plasma sample

Posted

Geometric Mean

Geometric Coefficient of Variation

milligrams per liter (mg/L)

preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4

ID	Title	Description
OG000	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).
OG001	Placebo + Chemotherapy	Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.

Secondary

Cmin of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel

Cmin was defined as the minimum observed plasma concentration of retifanlimab.

PK Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

mg/L

preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4

ID	Title	Description
OG000	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).
OG001	Placebo + Chemotherapy	Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
OG002

Secondary

Tmax of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel

tmax was defined as the time to the maximum serum concentration of retifanlimab.

PK Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

hours

preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4

ID	Title	Description
OG000	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).
OG001	Placebo + Chemotherapy	Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
OG002

Secondary

AUC of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel

AUC was defined as the area under the serum concentration versus time curve.

PK Evaluable Population

Posted

Geometric Mean

Geometric Coefficient of Variation

day x mg/L

preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4

ID	Title	Description
OG000	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).
OG001	Placebo + Chemotherapy	Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
OG002

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	Placebo + Chemotherapy	Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.	38	152	59	152	151	152
EG001	Retifanlimab 500 mg Q4W + Chemotherapy	Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared [mg/m^2] on Days 1, 8, and 15).	53	154	73	154	154	154
EG002	Randomized Period Total	Randomized Period Total	91	306	132	306	305	306
EG003	Retifanlimab 500 mg Q4W	In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).	35	69	16	69	48	69

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG0030 events0 affected69 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected154 at risk EG0022 events2 affected306 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0012 events2 affected154 at risk EG0024 events4 affected306 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected154 at risk EG0022 events2 affected306 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0013 events3 affected154 at risk EG0025 events5 affected306 at risk EG003
Anal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected152 at risk EG0010 events0 affected154 at risk EG0023 events3 affected306 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected154 at risk EG0022 events2 affected306 at risk EG003
Anal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Appendicitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003
Ataxia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Bacterial pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected154 at risk EG0020 events0 affected306 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected154 at risk EG0022 events2 affected306 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Catheter site infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Cell death	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Central nervous system lesion	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected152 at risk EG0011 events1 affected154 at risk EG0023 events2 affected306 at risk EG003
Creatinine renal clearance decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected154 at risk EG0020 events0 affected306 at risk EG003
Device related infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected152 at risk EG0014 events4 affected154 at risk EG0028 events8 affected306 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected154 at risk EG0022 events2 affected306 at risk EG003
Embolic cerebral infarction	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected154 at risk EG0020 events0 affected306 at risk EG003
Embolism	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Erysipelas	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected152 at risk EG0011 events1 affected154 at risk EG0023 events2 affected306 at risk EG003
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0012 events2 affected154 at risk EG0024 events4 affected306 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0011 events1 affected154 at risk EG0023 events3 affected306 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Fungating wound	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected154 at risk EG0020 events0 affected306 at risk EG003
General physical health deterioration	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected154 at risk EG0020 events0 affected306 at risk EG003
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Hepatic pain	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0011 events1 affected154 at risk EG0023 events3 affected306 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected154 at risk EG0022 events2 affected306 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected154 at risk EG0020 events0 affected306 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected154 at risk EG0020 events0 affected306 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003
Hypophysitis	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Immune-mediated cholangitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Immune-mediated enterocolitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003
Inadequate analgesia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Infected fistula	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0012 events1 affected154 at risk EG0022 events1 affected306 at risk EG003
Inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Influenza like illness	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Klebsiella infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003
Large intestine infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Lipase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected154 at risk EG0022 events2 affected306 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Lymph node haemorrhage	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Lymphocele	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected152 at risk EG0010 events0 affected154 at risk EG0023 events1 affected306 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Myasthenic syndrome	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0013 events3 affected154 at risk EG0023 events3 affected306 at risk EG003
Necrosis ischaemic	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Neutropenic colitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0012 events2 affected154 at risk EG0024 events4 affected306 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Orchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected152 at risk EG0010 events0 affected154 at risk EG0022 events1 affected306 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0010 events0 affected154 at risk EG0022 events2 affected306 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected152 at risk EG0012 events1 affected154 at risk EG0026 events5 affected306 at risk EG003
Pneumonia haemophilus	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0015 events5 affected154 at risk EG0026 events6 affected306 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected152 at risk EG0010 events0 affected154 at risk EG0024 events3 affected306 at risk EG003
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected152 at risk EG0013 events3 affected154 at risk EG0026 events6 affected306 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0012 events2 affected154 at risk EG0022 events2 affected306 at risk EG003
Rectal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0013 events2 affected154 at risk EG0023 events2 affected306 at risk EG003
Rectal perforation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Secondary adrenocortical insufficiency	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected152 at risk EG0015 events5 affected154 at risk EG0029 events9 affected306 at risk EG003
Skin infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected152 at risk EG0010 events0 affected154 at risk EG0022 events1 affected306 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Tumour fistulisation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0010 events0 affected154 at risk EG0020 events0 affected306 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Urethral fistula	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0012 events1 affected154 at risk EG0022 events1 affected306 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0010 events0 affected154 at risk EG0021 events1 affected306 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected152 at risk EG0012 events2 affected154 at risk EG0028 events7 affected306 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected152 at risk EG0014 events4 affected154 at risk EG0028 events7 affected306 at risk EG003
Warm autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected152 at risk EG0011 events1 affected154 at risk EG0021 events1 affected306 at risk EG003
Wound infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG0011 events1 affected154 at risk EG0022 events2 affected306 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00021 events17 affected152 at risk EG00119 events18 affected154 at risk EG00240 events35 affected306 at risk EG0035 events4 affected69 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00024 events17 affected152 at risk EG00118 events14 affected154 at risk EG00242 events31 affected306 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0009 events7 affected152 at risk EG00121 events16 affected154 at risk EG00230 events23 affected306 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00076 events75 affected152 at risk EG00183 events79 affected154 at risk EG002159 events154 affected306 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000170 events105 affected152 at risk EG001171 events102 affected154 at risk EG002341 events207 affected306 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG00011 events10 affected152 at risk EG00112 events9 affected154 at risk EG00223 events19 affected306 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00028 events21 affected152 at risk EG00129 events24 affected154 at risk EG00257 events45 affected306 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00012 events10 affected152 at risk EG00118 events13 affected154 at risk EG00230 events23 affected306 at risk EG003
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG000101 events60 affected152 at risk EG001108 events73 affected154 at risk EG002209 events133 affected306 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00024 events20 affected152 at risk EG00117 events16 affected154 at risk EG00241 events36 affected306 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected152 at risk EG00112 events9 affected154 at risk EG00218 events15 affected306 at risk EG003
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected152 at risk EG00110 events8 affected154 at risk EG00212 events9 affected306 at risk EG003
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00019 events19 affected152 at risk EG00121 events20 affected154 at risk EG00240 events39 affected306 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00085 events61 affected152 at risk EG00173 events55 affected154 at risk EG002158 events116 affected306 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00020 events16 affected152 at risk EG00122 events17 affected154 at risk EG00242 events33 affected306 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00053 events39 affected152 at risk EG00144 events37 affected154 at risk EG00297 events76 affected306 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000104 events61 affected152 at risk EG001158 events74 affected154 at risk EG002262 events135 affected306 at risk EG003
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00011 events10 affected152 at risk EG00111 events11 affected154 at risk EG00222 events21 affected306 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected152 at risk EG00111 events10 affected154 at risk EG00217 events16 affected306 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00014 events13 affected152 at risk EG00121 events20 affected154 at risk EG00235 events33 affected306 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected152 at risk EG0019 events8 affected154 at risk EG00214 events13 affected306 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00020 events18 affected152 at risk EG00125 events23 affected154 at risk EG00245 events41 affected306 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected152 at risk EG0017 events6 affected154 at risk EG00212 events11 affected306 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected152 at risk EG0019 events8 affected154 at risk EG00212 events11 affected306 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected152 at risk EG00116 events14 affected154 at risk EG00223 events21 affected306 at risk EG003
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG00080 events50 affected152 at risk EG00156 events45 affected154 at risk EG002136 events95 affected306 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected152 at risk EG00112 events9 affected154 at risk EG00215 events12 affected306 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected152 at risk EG0019 events9 affected154 at risk EG00215 events15 affected306 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00010 events9 affected152 at risk EG0014 events3 affected154 at risk EG00214 events12 affected306 at risk EG003
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00031 events16 affected152 at risk EG00129 events25 affected154 at risk EG00260 events41 affected306 at risk EG003
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00017 events11 affected152 at risk EG00117 events11 affected154 at risk EG00234 events22 affected306 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected152 at risk EG00112 events12 affected154 at risk EG00213 events13 affected306 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected152 at risk EG00111 events10 affected154 at risk EG00217 events16 affected306 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00020 events12 affected152 at risk EG00124 events19 affected154 at risk EG00244 events31 affected306 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00019 events16 affected152 at risk EG00118 events13 affected154 at risk EG00237 events29 affected306 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected152 at risk EG00115 events12 affected154 at risk EG00223 events20 affected306 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected152 at risk EG00123 events21 affected154 at risk EG00228 events26 affected306 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG00012 events10 affected152 at risk EG0018 events8 affected154 at risk EG00220 events18 affected306 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00029 events17 affected152 at risk EG00138 events20 affected154 at risk EG00267 events37 affected306 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00014 events9 affected152 at risk EG00130 events17 affected154 at risk EG00244 events26 affected306 at risk EG003
Mucosal inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG00012 events9 affected152 at risk EG00118 events17 affected154 at risk EG00230 events26 affected306 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00011 events11 affected152 at risk EG00114 events11 affected154 at risk EG00225 events22 affected306 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00019 events15 affected152 at risk EG00118 events12 affected154 at risk EG00237 events27 affected306 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000151 events87 affected152 at risk EG001153 events85 affected154 at risk EG002304 events172 affected306 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00051 events46 affected152 at risk EG00152 events46 affected154 at risk EG002103 events92 affected306 at risk EG003
Neurotoxicity	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00013 events13 affected152 at risk EG00112 events9 affected154 at risk EG00225 events22 affected306 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000199 events67 affected152 at risk EG001184 events73 affected154 at risk EG002383 events140 affected306 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00072 events34 affected152 at risk EG001104 events42 affected154 at risk EG002176 events76 affected306 at risk EG003
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG00033 events28 affected152 at risk EG00121 events21 affected154 at risk EG00254 events49 affected306 at risk EG003
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected152 at risk EG0011 events1 affected154 at risk EG0028 events7 affected306 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00010 events10 affected152 at risk EG00112 events10 affected154 at risk EG00222 events20 affected306 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00023 events18 affected152 at risk EG00132 events25 affected154 at risk EG00255 events43 affected306 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00015 events15 affected152 at risk EG00118 events17 affected154 at risk EG00233 events32 affected306 at risk EG003
Platelet count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00027 events15 affected152 at risk EG00152 events20 affected154 at risk EG00279 events35 affected306 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00021 events19 affected152 at risk EG00116 events14 affected154 at risk EG00237 events33 affected306 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00010 events10 affected152 at risk EG00141 events37 affected154 at risk EG00251 events47 affected306 at risk EG003
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG00028 events18 affected152 at risk EG00136 events21 affected154 at risk EG00264 events39 affected306 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00021 events12 affected152 at risk EG00129 events24 affected154 at risk EG00250 events36 affected306 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00013 events11 affected152 at risk EG00121 events17 affected154 at risk EG00234 events28 affected306 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected152 at risk EG0019 events9 affected154 at risk EG00211 events11 affected306 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00046 events31 affected152 at risk EG00138 events22 affected154 at risk EG00284 events53 affected306 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00025 events18 affected152 at risk EG00126 events16 affected154 at risk EG00251 events34 affected306 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00052 events30 affected152 at risk EG00150 events37 affected154 at risk EG002102 events67 affected306 at risk EG003
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00015 events13 affected152 at risk EG0017 events7 affected154 at risk EG00222 events20 affected306 at risk EG003
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00050 events20 affected152 at risk EG00159 events24 affected154 at risk EG002109 events44 affected306 at risk EG003

ID	Term
D002294	Carcinoma, Squamous Cell
D001005	Anus Neoplasms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018307	Neoplasms, Squamous Cell
D012004	Rectal Neoplasms
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D007410	Intestinal Diseases
D001004	Anus Diseases
D012002	Rectal Diseases

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes