NCT02112045 · OUTCOME

Number of Participants With Adverse Events

A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation · Source last updated 2019-11-26

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up through Day 30

What was measured

-Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Groups in this outcome

Experimental: Granix and High Dose Melphalan (HDM)

Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0

Control: High Dose Melphalan (HDM)

HDM intravenously (IV) on Day -2.

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
Experimental: Granix and High Dose Melphalan (HDM)	45
Control: High Dose Melphalan (HDM)	45

Reported measurements

Febrile neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	30	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	27	Not reported	Not reported	Not reported	Not reported

Atrial fibrillation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported

Left ventricular systolic function

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Sinus tachycardia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported

Excessive cerumen

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Impacted cerumen

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Dry eye

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Abdominal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported

Colitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Colonic perforation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Constipation

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Diarrhea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	5	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	11	Not reported	Not reported	Not reported	Not reported

Enterocolitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Epigastric pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Esophagitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Hemorrhoids

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported

Ileus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Mucositis oral

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	16	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	14	Not reported	Not reported	Not reported	Not reported

Nausea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	5	Not reported	Not reported	Not reported	Not reported

Oral pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Upper gastrointestinal hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Edema limbs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Fever

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	5	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	4	Not reported	Not reported	Not reported	Not reported

Infusion related reaction

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Malaise

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Allergic reaction

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Bacteremia-Coagulase negative staphyococcus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Bacteremia - Enterobacter Clocae

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Bacteremia - Fusobacterium

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Bacteremia - MSSA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Bacteremia - Pseudomonas Aeruginosa

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Bacteremia - Streptococcus mitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Candida (groin)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Clostridium difficile

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Lung infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported

Mucosal infection (oral thrush)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	10	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	11	Not reported	Not reported	Not reported	Not reported

Peri-rectal yeast infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Sepsis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Skin infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported

Splenic infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Upper respiratory infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	4	Not reported	Not reported	Not reported	Not reported

Urinary tract infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	4	Not reported	Not reported	Not reported	Not reported

Vaginal infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Bleeding from CVC insertion site

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Fall

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Activated partial thromboplastin time prolonged

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported

Creatinine increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	4	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported

Electrocardiogram QT corrected interval prolonged

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Weight loss

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	6	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Anorexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Dehydration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	6	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported

Hypernatremia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Hyperuricemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Hypoalbuminemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	18	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	20	Not reported	Not reported	Not reported	Not reported

Hypocalcemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	25	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	22	Not reported	Not reported	Not reported	Not reported

Hypokalemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	16	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	16	Not reported	Not reported	Not reported	Not reported

Hyponatremia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	4	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	40	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	35	Not reported	Not reported	Not reported	Not reported

Bone pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	4	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Muscle cramps-back/legs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Right thigh/leg pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Acitinic Keratosis (right shoulder)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Headache

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Reversible posterior leukoencephalopathy syndrome

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Syncope

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Tremor

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Anxiety

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported

Delirium

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Insomnia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Hematuria

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Proteinuria

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported

Cough

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Dyspnea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Hypoxia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	8	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	5	Not reported	Not reported	Not reported	Not reported

Pleural effusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Pulmonary edema

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Wheezing

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Erythematous nodules

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Pruritus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported

Rash acneiform

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Rash maculo-papular

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Skin lesion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Flushing

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Hematoma

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	5	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	12	Not reported	Not reported	Not reported	Not reported

Phlebitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Thromboembolic event

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported

Atrial flutter

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Myocardial infarction

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Palpitations

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Supraventricular tachycardia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Adrenal insufficiency

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

SIADH

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Dyspepsia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Dysphagia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Hemorrhoidal hemorrhage

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Odynophagia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Chills

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Multi-organ failure

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Non-cardiac chest pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Bacteremia - Gram Positive

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Bacteremia-Serratia liquefaciens/pantoea species

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Catheter related infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

CMV viremia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Esophageal infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Otitis media

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Rhinitis infective

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	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
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Alkaline phosphatase increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

INR increased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Hyperglycemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	3	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Uncontrolled Diabetes Mellitus

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	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
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Jaw pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Joint effusion

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Encephalopathy

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	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
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Presyncope

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	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
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Urinary frequency

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Urinary retention

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Urinary tract pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Scrotal pain

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Atelectasis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Epistaxis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Hiccups

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Pneumonitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	2	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Productive cough

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Respiratory failure

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Sore throat

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Facial rash/dermatitis

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Follicular rash-back/posterior neck

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Rash forehead/back

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Skin ulceration

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Experimental: Granix and High Dose Melphalan (HDM)	1	Not reported	Not reported	Not reported	Not reported
Control: High Dose Melphalan (HDM)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
30
group Id
OG001
value
27
title
Febrile neutropenia
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
title
Atrial fibrillation
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Left ventricular systolic function
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
title
Sinus tachycardia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Excessive cerumen
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Impacted cerumen
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Dry eye
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
title
Abdominal pain
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Colitis
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Colonic perforation
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Constipation
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
11
title
Diarrhea

denoms

counts
group Id
OG000
value
45
group Id
OG001
value
45
units
Participants

description

-Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

groups

description
Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0
id
OG000
title
Experimental: Granix and High Dose Melphalan (HDM)
description
HDM intravenously (IV) on Day -2.
id
OG001
title
Control: High Dose Melphalan (HDM)

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Up through Day 30

title

Number of Participants With Adverse Events

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice