Table 3 Toxicities assessed during and after radiotherapy according to the CTC AE v5.0 criteria

Proctitis –

A disorder characterized by inflammation of the rectum.

Rectal discomfort, intervention not indicated

Symptomatic (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL

Severe symptoms; fecal urgency or stool incontinence; limiting self care ADL

Life-threatening consequences; urgent intervention indicated

Death

Diarrhea –

A disorder characterized by an increase in frequency and/or loose or watery bowel movements.

Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline

Increase of 4–6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL

Increase of > = 7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL

Life-threatening consequences; urgent intervention indicated

Death

Cystitis noninfective – A disorder characterized by inflammation of the bladder which is not caused by an infection of the urinary tract

Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinence

Moderate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL

Gross hematuria; transfusion, IV medications, or hospitalization indicated; elective invasive intervention indicated

Life-threatening consequences; urgent invasive intervention indicated

Death

Anal mucositis –

A disorder characterized by ulceration or inflammation of the mucous membrane of the anus

Asymptomatic or mild symptoms; intervention not indicated

Symptomatic; medical intervention indicated; limiting instrumental ADL

Severe symptoms; limiting self care ADL

–

–

Vaginal dryness –

A disorder characterized by an uncomfortable feeling of itching and burning in the vagina

Mild vaginal dryness not interfering with sexual function

Moderate vaginal dryness interfering with sexual function or causing frequent discomfort

Severe vaginal dryness resulting in dyspareunia or severe discomfort

–

–

Vaginal discharge –

A disorder characterized by vaginal secretions

Mild vaginal discharge (greater than baseline for patient)

Moderate to heavy vaginal discharge; use of perineal pad or tampon indicated

–

–

–

Vaginal inflammation - A disorder characterized by inflammation involving the vagina. Symptoms may include redness, edema, marked discomfort and an increase in vaginal discharge

Mild discomfort or pain, edema, or redness

Moderate discomfort or pain, edema, or redness; limiting instrumental ADL

Severe discomfort or pain, edema, or redness; limiting self care ADL; small areas of mucosal ulceration

Life-threatening consequences; widespread areas of mucosal ulceration; urgent intervention indicated

–

Vaginal stricture –

A disorder characterized by a narrowing of the vaginal canal

Asymptomatic; mild vaginal shortening or narrowing

Vaginal narrowing and/or shortening not interfering with physical examination

Vaginal narrowing and/or shortening interfering with the use of tampons, sexual activity or physical examination

–

Death