Trial Outcomes & Findings for Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors (NCT NCT00053352)

Last Updated: 2021-07-13

Results Overview

Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

302 participants

Primary outcome timeframe

3 Years after enrollment

Results posted on

2021-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Experimental	Arm 2 No intervention
Overall Study STARTED	190	112
Overall Study COMPLETED	169	102
Overall Study NOT COMPLETED	21	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Experimental	Arm 2 No intervention
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	11	1
Overall Study Withdrawal by Subject	1	0
Overall Study Ineligible	8	8
Overall Study Disease at new site	1	0

Baseline Characteristics

Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=190 Participants Experimental	Arm 2 n=112 Participants No intervention	Total n=302 Participants Total of all reporting groups
Age, Continuous	9.57 years STANDARD_DEVIATION 5.65 • n=99 Participants	5.41 years STANDARD_DEVIATION 5.93 • n=107 Participants	8.02 years STANDARD_DEVIATION 6.09 • n=206 Participants
Sex: Female, Male Female	145 Participants n=99 Participants	29 Participants n=107 Participants	174 Participants n=206 Participants
Sex: Female, Male Male	45 Participants n=99 Participants	83 Participants n=107 Participants	128 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Asian	14 Participants n=99 Participants	10 Participants n=107 Participants	24 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Black or African American	22 Participants n=99 Participants	8 Participants n=107 Participants	30 Participants n=206 Participants
Race (NIH/OMB) White	128 Participants n=99 Participants	72 Participants n=107 Participants	200 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=99 Participants	18 Participants n=107 Participants	42 Participants n=206 Participants
Region of Enrollment New Zealand	2 participants n=99 Participants	3 participants n=107 Participants	5 participants n=206 Participants
Region of Enrollment Canada	16 participants n=99 Participants	8 participants n=107 Participants	24 participants n=206 Participants
Region of Enrollment United States	170 participants n=99 Participants	91 participants n=107 Participants	261 participants n=206 Participants
Region of Enrollment Australia	1 participants n=99 Participants	8 participants n=107 Participants	9 participants n=206 Participants
Region of Enrollment Switzerland	0 participants n=99 Participants	2 participants n=107 Participants	2 participants n=206 Participants
Region of Enrollment Guam	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants

PRIMARY outcome

Timeframe: 3 Years after enrollment

Population: 181 patients were evaluated for event free survival through 3 years for patients enrolled on Arm 1. Event-free survival is not a primary outcome measure for Arm 2 patients.

Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.

Outcome measures

Outcome measures
Measure	Arm 1 n=181 Participants Experimental	Arm 2 No intervention
Event-Free Survival (EFS)	87.0 Percent probability Interval 81.0 to 92.0	—

PRIMARY outcome

Timeframe: 3 Years after enrollment

Percentage probability of being alive at 3 years following enrollment.

Outcome measures

Outcome measures
Measure	Arm 1 n=181 Participants Experimental	Arm 2 n=104 Participants No intervention
Overall Survival (OS)	97.0 Percent Probability Interval 93.0 to 99.0	99.0 Percent Probability Interval 92.8 to 99.9

SECONDARY outcome

Timeframe: Up to 126 days after the start of chemotherapy

Population: 182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint

Calculated to quantify the treatment cost associated with this regimen.

Outcome measures

Outcome measures
Measure	Arm 1 n=182 Participants Experimental	Arm 2 No intervention
Days Hospitalized for Patients Who Receive Chemotherapy	14.08 Days in the hospital Standard Deviation 10.27	—

SECONDARY outcome

Timeframe: Up to 126 days after the start of chemotherapy

Population: 182 patients were enrolled on intermediate risk chemotherapy and were evaluable for this secondary endpoint

The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy

Outcome measures

Outcome measures
Measure	Arm 1 n=182 Participants Experimental	Arm 2 No intervention
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Abdominal pain	3 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Acute kidney injury	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Lymphocyte count decrease	2 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Iincrease in alanine aminotransferase	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Neutrophil count decrease	58 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Anemia	10 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Increase in aspartate aminotransferase	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Catheter related infection	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Constipation	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Dehydration	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Encephalopathy	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Febrile neutropenia	9 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Fever	3 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Hyperglycemia	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Hyperkalemia	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Hypocalcemia	2 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Hypokalemia	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Hypomagnesemia	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Hyponatremia	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Hypophosphatemia	6 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Small intestine obstruction	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Nausea	5 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Non-cardiac chest pain	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Other gastrointestinal disorders	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Other infection	10 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Platelet count decrease	7 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Syncope	1 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Vomiting	4 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 White blood cell decrease	17 patients	—
Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Wound infection	1 patients	—

Adverse Events

Arm 2 (Observation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm I (Chemotherapy)

Serious events: 0 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Arm 2 (Observation) n=104 participants at risk Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm. Observation only for recurrence or development of an SMN	Arm I (Chemotherapy) n=182 participants at risk Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes \& etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over ≥ 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 \& 6). After completion of compressed induction chemotherapy, patients with no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or abnormal tumor markers proceed to conventional surgery (2nd-look) and/or 3 more courses of compressed consolidation chemotherapy. After surgery, patients with pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy. Patients receive cisplatin, etoposide, and bleomycin as induction chemotherapy in weeks 10,13, \& 16. con
Gastrointestinal disorders Abdominal pain	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	1.6% 3/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Renal and urinary disorders Acute kidney injury	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Investigations Alanine aminotransferase increased	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Blood and lymphatic system disorders Anemia	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	5.5% 10/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Investigations Aspartate aminotransferase increased	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Infections and infestations Catheter related infection	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Gastrointestinal disorders Constipation	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Metabolism and nutrition disorders Dehydration	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Nervous system disorders Encephalopathy	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	4.9% 9/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
General disorders Fever	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	1.6% 3/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Ear and labyrinth disorders Hearing impaired	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	1.1% 2/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	3.3% 6/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Gastrointestinal disorders Ileus	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.00% 0/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	5.5% 10/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Investigations Lymphocyte count decreased	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	1.1% 2/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Gastrointestinal disorders Nausea	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	2.7% 5/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Investigations Neutrophil count decreased	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	31.9% 58/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
General disorders Non-cardiac chest pain	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Investigations Platelet count decreased	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	3.8% 7/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Nervous system disorders Syncope	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Infections and infestations Urinary tract infection	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.00% 0/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Gastrointestinal disorders Vomiting	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	2.2% 4/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Investigations White blood cell decreased	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	9.3% 17/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.
Infections and infestations Wound infection	0.00% 0/104 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.	0.55% 1/182 Only patients who are considered eligible contribute to the tabulation of adverse events. For Arm/Group Title "No Intervention" (Arm/Group Description: "Arm 2") 104 eligible patients contribute as described from the Participant Flow as 112 enrolled minus 8 ineligible. For Arm/Group Title "Experimental" (Arm/Group Description: "Arm 1") 182 eligible patients contribute as described from the Participant Flow as 190 enrolled minus 8 ineligible.