NCT01272037 · OUTCOME

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer · Source last updated 2026-08-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Participants
Interval / dispersion: Not reported
Time frame: Duration of treatment and follow-up until death or 3 years after randomization

What was measured

Only adverse events that are possibly, probably, or definitely related to study drug are reported. Assessed at 6, 12, 24, and 36 months after randomization.

Analysis population: Eligible participants who received at least one dose of protocol treatment and assessed for Adverse Event.

Groups in this outcome

Chemo and Endocrine Therapy

Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.

Endocrine Therapy Alone

Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Chemo and Endocrine Therapy	2062
Endocrine Therapy Alone	2342

Reported measurements

Abdominal infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Abdominal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	7	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Acute kidney injury

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	2	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Allergic reaction

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	6	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Anemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	20	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Anxiety

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Arthralgia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	48	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	35	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	0	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Atrial fibrillation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Back pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Blood and lymphatic system disorders - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Bone marrow hypocellular

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Bone pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	15	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	5	Not reported	Not reported	Not reported	Not reported

Breast infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Bronchial infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

CD4 lymphocytes decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Cardiac arrest

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Cataract

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	0	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Catheter related infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Chest pain - cardiac

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Chest wall pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	0	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Colitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	5	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Death NOS

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	0	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Dehydration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	11	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Depression

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	6	Not reported	Not reported	Not reported	Not reported

Dermatitis radiation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	4	Not reported	Not reported	Not reported	Not reported

Device related infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	31	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	3	Not reported	Not reported	Not reported	Not reported

Dizziness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Dry mouth

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Dry skin

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Dyspareunia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Dyspepsia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Dyspnea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Ear pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Edema limbs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Ejection fraction decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Erythema multiforme

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Erythroderma

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Esophagitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	48	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	9	Not reported	Not reported	Not reported	Not reported

Febrile neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	83	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Fever

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Flank pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Flu like symptoms

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

GGT increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Gastric hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Gastric ulcer

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Gastrointestinal disorders - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Gastrointestinal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

General disorders and admin site conditions - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Generalized muscle weakness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	7	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Heart failure

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Hematuria

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Hemorrhoids

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Hot flashes

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	12	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	14	Not reported	Not reported	Not reported	Not reported

Hyperglycemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	16	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Hyperhidrosis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	8	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	6	Not reported	Not reported	Not reported	Not reported

Hypokalemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	5	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Hyponatremia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

INR increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	0	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Infections and infestations - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Injection site reaction

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Insomnia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	9	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	4	Not reported	Not reported	Not reported	Not reported

Irregular menstruation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Joint range of motion decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Kidney infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Left ventricular systolic dysfunction

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Leukemia secondary to oncology chemotherapy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Leukocytosis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Lipase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Localized edema

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Lung infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	6	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Lymphedema

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Lymphocyte count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	20	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Menorrhagia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	0	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Mucositis oral

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	23	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Muscle weakness lower limb

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Musculoskeletal and connective tiss disorder - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Myalgia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	24	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	8	Not reported	Not reported	Not reported	Not reported

Myelitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Myocardial infarction

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	21	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Neck pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Neoplasms benign, malignant and unspecified - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Nervous system disorders - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Neutrophil count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	150	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Osteoporosis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Pain in extremity

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Palmar-plantar erythrodysesthesia syndrome

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	7	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Paresthesia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Peripheral ischemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	0	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Peripheral motor neuropathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Peripheral sensory neuropathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	21	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	2	Not reported	Not reported	Not reported	Not reported

Platelet count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Pleuritic pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Pneumonitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	8	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Premature menopause

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Pruritus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	5	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Radiation recall reaction (dermatologic)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Rash acneiform

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Rash maculo-papular

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	8	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	2	Not reported	Not reported	Not reported	Not reported

Renal and urinary disorders - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Reproductive system and breast disorders - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Sepsis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	5	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Sinus tachycardia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Skin and subcutaneous tissue disorders - Other

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	6	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	5	Not reported	Not reported	Not reported	Not reported

Skin infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	9	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Skin ulceration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Stroke

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	3	Not reported	Not reported	Not reported	Not reported

Suicidal ideation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Supraventricular tachycardia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Surgical and medical procedures - Other, specify

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	4	Not reported	Not reported	Not reported	Not reported

Syncope

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	3	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Thromboembolic event

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	9	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	4	Not reported	Not reported	Not reported	Not reported

Tinnitus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Typhlitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Upper gastrointestinal hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Upper respiratory infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Urinary tract infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Urticaria

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Uterine hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	0	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Vaginal dryness

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	0	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	4	Not reported	Not reported	Not reported	Not reported

Vaginal hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Vascular access complication

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Vomiting

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	19	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Watering eyes

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Weight gain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	4	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	1	Not reported	Not reported	Not reported	Not reported

Weight loss

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	2	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

White blood cell decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	65	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Wound dehiscence

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemo and Endocrine Therapy	1	Not reported	Not reported	Not reported	Not reported
Endocrine Therapy Alone	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Abdominal infection
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
0
title
Abdominal pain
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Acute kidney injury
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Alkaline phosphatase increased
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
1
title
Allergic reaction
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
0
title
Anemia
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
Anorexia
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1
title
Anxiety
categories
measurements
group Id
OG000
value
48
group Id
OG001
value
35
title
Arthralgia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
title
Atrial fibrillation

denoms

counts
group Id
OG000
value
2062
group Id
OG001
value
2342
units
Participants

description

Only adverse events that are possibly, probably, or definitely related to study drug are reported. Assessed at 6, 12, 24, and 36 months after randomization.

groups

description
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
id
OG000
title
Chemo and Endocrine Therapy
description
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
id
OG001
title
Endocrine Therapy Alone

param Type

NUMBER

population Description

Eligible participants who received at least one dose of protocol treatment and assessed for Adverse Event.

reporting Status

POSTED

time Frame

Duration of treatment and follow-up until death or 3 years after randomization

title

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice