CTCAE RápidoAdverse event grades · CTCAE v6.0

Reproductive system and breast disorders

The 47 CTCAE v6.0 adverse events in Reproductive system and breast disorders, with grades 1 to 5.

  1. G1Not applicable
  2. G2Present
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the abnormal absence of menses for at least three consecutive menstrual cycles.

MedDRA code (LLT): 10001927 · CTCAE v6.0 (NCI), original English text.

  1. G1Not applicable
  2. G2Absence of sperm in ejaculate
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by laboratory test results that indicate complete absence of spermatozoa in the semen.

MedDRA code (LLT): 10003883 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the breast region.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10006298 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by abnormally painful abdominal cramps during menses.

MedDRA code (LLT): 10013934 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild discomfort or pain associated with vaginal penetration; discomfort relieved with use of vaginal lubricants or estrogen
  2. G2Moderate discomfort or pain associated with vaginal penetration; discomfort or pain partially relieved with use of vaginal lubricants or estrogen
  3. G3Severe discomfort or pain associated with vaginal penetration; discomfort or pain unrelieved by vaginal lubricants or estrogen
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by painful or difficult coitus.

MedDRA code (LLT): 10013941 · CTCAE v6.0 (NCI), original English text.

  1. G1Diminished ejaculation
  2. G2Anejaculation or retrograde ejaculation
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by problems related to ejaculation. This category includes premature, delayed, retrograde and painful ejaculation.

MedDRA code (LLT): 10014326 · CTCAE v6.0 (NCI), original English text.

  1. G1Decrease in erectile function (frequency or rigidity of erections) but intervention not indicated (e.g., medication or use of mechanical device, penile pump)
  2. G2Decrease in erectile function (frequency/rigidity of erections), erectile intervention indicated, (e.g., medication or mechanical devices such as penile pump)
  3. G3Decrease in erectile function (frequency/rigidity of erections) but erectile intervention not helpful (e.g., medication or mechanical devices such as penile pump); placement of a permanent penile prosthesis indicated (not previously present)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the persistent or recurrent inability to achieve or to maintain an erection during sexual activity.

MedDRA code (LLT): 10061461 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; elective intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the contents in the fallopian tube.

MedDRA code (LLT): 10065789 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; medical intervention indicated
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the development of secondary female sex characteristics in males due to extrinsic factors.

MedDRA code (LLT): 10054382 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic
  2. G2Symptomatic (e.g., pain or psychosocial impact)
  3. G3Severe symptoms; elective operative intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by excessive development of the breasts in males.

MedDRA code (LLT): 10018801 · CTCAE v6.0 (NCI), original English text.

  1. G1Minimal bleeding identified on imaging study or laparoscopy; intervention not indicated
  2. G2Moderate bleeding; medical intervention indicated
  3. G3Invasive intervention indicated; hospitalization
  4. G4Life-threatening consequences; urgent operative intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by the presence of blood in a fallopian tube.

MedDRA code (LLT): 10060602 · CTCAE v6.0 (NCI), original English text.

  1. G1Intermittent/irregular menses for <=3 consecutive menstrual cycles
  2. G2Intermittent/irregular menses for >3 consecutive menstrual cycles
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a change in cycle or duration of menses from baseline.

Navigational noteConsider Reproductive system and breast disorders: Amenorrhea.

MedDRA code (LLT): 10022992 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild changes in lactation, not significantly affecting production or expression of breast milk
  2. G2Changes in lactation, significantly affecting breast production or expression of breast milk
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by disturbances of milk secretion. It is not necessarily related to pregnancy that is observed in females and can be observed in males.

MedDRA code (LLT): 10061261 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild; iron supplements indicated
  2. G2Moderate symptoms; medical intervention indicated (e.g., hormones)
  3. G3Hospitalization; operative intervention indicated (e.g., hysterectomy)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by abnormally heavy vaginal bleeding during menses.

MedDRA code (LLT): 10027313 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; asymmetry with slight retraction and/or thickening of the nipple areolar complex
  2. G2Symptomatic; asymmetry of nipple areolar complex with moderate retraction and/or thickening of the nipple areolar complex
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an abnormality of the nipple.

MedDRA code (LLT): 10065823 · CTCAE v6.0 (NCI), original English text.

  1. G1Sperm concentration >0 to <15 million/ml
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a decrease in the number of spermatozoa in the semen.

MedDRA code (LLT): 10030300 · CTCAE v6.0 (NCI), original English text.

  1. G1Intermittent/irregular menses for 3 consecutive months with basal FSH levels >25 IU/L but less than postmenopausal range
  2. G2Amenorrhea for 3 consecutive months with basal FSH levels >40 IU/L or in the postmenopausal range
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by the development of oligomenorrhea or amenorrhea for at least 3 consecutive months and serum follicle-stimulating hormone (FSH) levels in the menopausal range before age 40. Symptoms of estrogen deficiency may include hot flashes, night sweats, mood swings, and vaginal dryness. Laboratory findings include elevated serum FSH. Other supportive laboratory findings include decreased serum estradiol and anti-Mullerian hormone (AMH) levels.

MedDRA code (LLT): 10033169 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the ovary.

MedDRA code (LLT): 10065763 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic and intervention not indicated
  3. G3Transfusion; invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by tearing or disruption of the ovarian tissue.

MedDRA code (LLT): 10033279 · CTCAE v6.0 (NCI), original English text.

  1. G1Not applicable
  2. G2Present
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in one side of the abdomen between menstrual cycles, around the time of the discharge of the ovum from the ovarian follicle.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10033314 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic, not interfering with bladder, bowel, or vaginal function; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a reduction in the strength of the muscles of the pelvic floor.

MedDRA code (LLT): 10064026 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the pelvis.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10034263 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the penis.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10034310 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the area between the genital organs and the anus.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10061339 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the prostate gland.

MedDRA code (LLT): 10055325 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; elective intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by compression of the urethra secondary to enlargement of the prostate gland. This results in voiding difficulties (straining to void, slow urine stream, and incomplete emptying of the bladder).

MedDRA code (LLT): 10055026 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the prostate gland.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10036968 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of existing hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

MedDRA code (LLT): 10038604 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the scrotal area.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10039757 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the spermatic cord.

MedDRA code (LLT): 10065762 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; elective intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by blockage of the normal flow of the contents of the spermatic cord.

MedDRA code (LLT): 10065805 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic but not interfering with sexual function; intervention not indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; interfering with sexual function; intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by abnormal function or appearance of the testis.

Navigational noteConsider other AE terms in the Renal and urinary disorders SOC or Reproductive system and breast disorders SOC.

MedDRA code (LLT): 10043306 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the testis.

MedDRA code (LLT): 10055347 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the testis.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10043345 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the uterus and another organ or anatomic site.

MedDRA code (LLT): 10065811 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the uterus.

MedDRA code (LLT): 10046789 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; elective intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by blockage of the uterine outlet.

MedDRA code (LLT): 10065928 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the uterus.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10046809 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild vaginal discharge (greater than baseline for patient)
  2. G2Moderate to heavy vaginal discharge; use of perineal pad or tampon indicated
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years.

MedDRA code (LLT): 10046901 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild vaginal dryness not interfering with sexual function
  2. G2Moderate vaginal dryness interfering with sexual function or causing frequent discomfort
  3. G3Severe vaginal dryness resulting in dyspareunia or severe discomfort
  4. G4Not applicable
  5. G5Not applicable
Definition and note

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

MedDRA code (LLT): 10046904 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic
  2. G2Symptomatic, invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by an abnormal communication between the vagina and another organ or anatomic site.

MedDRA code (LLT): 10065813 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; intervention indicated
  3. G3Hospitalization
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by bleeding from the vagina.

MedDRA code (LLT): 10046912 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild discomfort or pain, edema, or redness
  2. G2Moderate discomfort or pain, edema, or redness; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe discomfort or pain, edema, or redness; small areas of mucosal ulceration; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; widespread areas of mucosal ulceration; urgent intervention indicated
  5. G5Not applicable
Definition and note

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

MedDRA code (LLT): 10046916 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; clinical or diagnostic observations only; intervention not indicated
  2. G2Symptomatic; elective intervention indicated
  3. G3Severe symptoms; invasive intervention indicated
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by blockage of vaginal canal.

MedDRA code (LLT): 10065817 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild pain
  2. G2Moderate pain; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe pain; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a sensation of marked discomfort in the vagina.

Navigational noteRecord final diagnosis/cause once determined.

MedDRA code (LLT): 10046937 · CTCAE v6.0 (NCI), original English text.

  1. G1Not applicable
  2. G2Invasive intervention not indicated
  3. G3Invasive intervention indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a rupture in the vaginal wall.

MedDRA code (LLT): 10065818 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic; mild vaginal shortening or narrowing
  2. G2Vaginal narrowing and/or shortening not interfering with physical examination
  3. G3Vaginal narrowing and/or shortening interfering with the use of tampons, sexual activity or physical examination
  4. G4Not applicable
  5. G5Death
Definition and note

DefinitionA disorder characterized by a narrowing of the vaginal canal.

MedDRA code (LLT): 10053496 · CTCAE v6.0 (NCI), original English text.

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