Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT

• Sponsor: Xiamen Amoytop Biotech Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01232504
• Collaborator: Shanghai Jiao Tong University Affiliated First People's Hospital (Other)
• Enrollment: 206
• Locations: 5
• Arms: 3
• Duration (Months): 45
• Patients Per Site: 41.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.

Condition or Disease	Intervention/Treatment	Phase
Mycoses	Drug: rhGM-CSF group; Drug: rhG-CSF+rhGM-CSF group; Drug: rhG-CSF group	Phase 4

Detailed Description

From Sept 2009 to Dec 2012, we recruited consecutive patients with hematological diseases undergoing allogeneic stem cell transplantation at 5 institutions in China. Recipients between ages of 14 to 60 years old were eligible. Eligible patients were randomized to receive once daily subcutaneous 5-7μg/kg/d GM-CSF (Molgramostim, TOPLEUCON®; Xiamen Amoytop Biotech Co., Ltd., China) (GM-CSF group), 5-7μg/kg/d G-CSF (G-CSF group), or a combination of 2-3μg/kg/d GM-CSF and 2-3μg/kg/d G-CSF each (G-CSF+GM-CSF group). Administration of CSFs was started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). If absolute neutrophil count (ANC) decreased to < 1.5×10(9)/L within 5 days after withdrawal of CSFs, the same CSF would be resumed until the absolute neutrophil count (ANC) reached 1.5×10(9)/L again. All patients received antimicrobial prophylaxis with oral levofloxacin 500 mg daily and antifungal prophylaxis with oral fluconazole 200 mg daily.

Study Design

• Study Type: Interventional
• Actual Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Granulocyte-macrophage Stimulating Factor on Prevention and Treatment of Invasive Fungal Diseases in the Recipients of Allogeneic Stem Cell Transplantation: A Prospective Multicenter Randomized Phase 4 Trial
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rhGM-CSF group subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily	Drug: rhGM-CSF group; subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).; Other Names: Topleucon® Granulocyte Macrophage Colony Stimulating Factor
Active Comparator: rhG-CSF+rhGM-CSF group a combination of 2-3μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) and 2-3μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) each	Drug: rhG-CSF+rhGM-CSF group; a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).; Other Names: Topleucon® Granulocyte Macrophage Colony Stimulating Factor Granulocyte Colony Stimulating Factor
Active Comparator: rhG-CSF group subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily	Drug: rhG-CSF group; subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).; Other Names: Granulocyte Colony Stimulating Factor Topleucon®

Outcome Measures

Primary Outcome Measures

1. Incidences of Invasive Fungal Diseases (IFD) [100 day post transplant]

   The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation

Secondary Outcome Measures

1. Hematological Engraftment [100 days post transplant]

   The median time of neutrophil and platelet recovery .

2. Transplant Related Mortality [100 days post transplant]

   Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).

3. Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD) [100 days post transplant]

   Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading).

4. IFD Related Mortality [3-1099 days]

   IFD-related mortalities after a median follow-up of 600 days.

5. Relapse Related Mortality [3～1099 days]

   Relapse related mortality after a median follow-up of 600 days.

6. Graft Versus Host Disease (aGVHD) Related Mortality [3-1099 days]

   Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days .

7. Hemorrhage Related Mortality [3-1099 days]

   Hemorrhage related mortality after a median follow-up of 600 days

8. Infection Related Mortality [3～1099 days)]

   Infection related mortality after a median follow-up of 600 days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 14~60 years old

• Allogenic hematological stem cell transplantation(HSCT) patients.

• Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase < 2 upper limit of normal, and/or total bilirubin < 2.5 upper limit of normal, creatinine < upper limit of normal.

• Informed consent.

Exclusion Criteria:

• Evidence of proven, probable or possible fungal infection at the time of enrollment.

• Patients were receiving anti-fungal treatment with proven SFI before transplantation.

• A history of hypersensitivity to G-CSF or GM-CSF.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China	530021
2	Henan Cancer Hospital	Zhengzhou	Henan	China	450003
3	Wuhan Tongji Hospital	Wuhan	Hubei	China	430030
4	Shanghai First People's Hospital	Shanghai	Shanghai	China	200080
5	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China	830054

Sponsors and Collaborators

• Xiamen Amoytop Biotech Co., Ltd.
• Shanghai Jiao Tong University Affiliated First People's Hospital

Investigators

• Principal Investigator: Chun Wang, M.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01232504
• Other Study ID Numbers: L-09-01
• First Posted: Nov 2, 2010
• Last Update Posted: Nov 4, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Xiamen Amoytop Biotech Co., Ltd.: Allo-HSCT; rhGM-CSF; Systemic fungal infection (SFI)
• Additional relevant MeSH terms: Mycoses; Molgramostim; Lenograstim; Sargramostim

Study Results

Participant Flow

Arm/Group Title	rhGM-CSF Group	rhG-CSF+ rhGM-CSF Group	rhG-CSF Group
Arm/Group Description	subcutaneous recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) and 2-3μg/kg/d recombinant human granulocyte stimulating factor (rhG-CSF) each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous recombinant human granulocyte stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Period Title: Overall Study
STARTED	68	69	69
COMPLETED	59	67	61
NOT COMPLETED	9	2	8

Baseline Characteristics

Arm/Group Title	rhGM-CSF Group	rhG-CSF+ rhGM-CSF Group	rhG-CSF Group	Total
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	Total of all reporting groups
Overall Participants	68	69	69	206
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	30.68	32.55	32.04	31.75
Age (Count of Participants)
<=18 years	8 11.8%	5 7.2%	9 13%	22 10.7%
Between 18 and 65 years	60 88.2%	64 92.8%	60 87%	184 89.3%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	17 25%	32 46.4%	25 36.2%	74 35.9%
Male	51 75%	37 53.6%	44 63.8%	132 64.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	68 100%	69 100%	69 100%	206 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	68 100%	69 100%	69 100%	206 100%

Outcome Measures

1. Secondary Outcome

Title	Hematological Engraftment
Description	The median time of neutrophil and platelet recovery .
Time Frame	100 days post transplant

Outcome Measure Data

Analysis Population Description

The number of intention-to-treat patients is 206. The hematological engraftment analysis within 100 day is based on intention-to-treat (ITT)patients .

Arm/Group Title	rhGM-CSF Group	rhG-CSF + rhGM-CSF Group	rhG-CSF Group
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Measure Participants	68	69	69
Median time for neutrophil recovery to 0.5×10(9)/L	13	11	11
Median time for platelet recovery to 50 × 10(9)/L	18	19	25

2. Secondary Outcome

Title	Transplant Related Mortality
Description	Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).
Time Frame	100 days post transplant

Outcome Measure Data

Analysis Population Description

The number of intention-to-treat patients is 206. The transplant related mortality analysis within 100 day is based on intention-to-treat (ITT) patients .

Arm/Group Title	rhGM-CSF Group	rhG-CSF+ rhGM-CSF Group	rhG-CSF Group
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Measure Participants	68	69	69
Number (95% Confidence Interval) [percentage of participants]	8.8 12.9%	8.7 12.6%	21.7 31.4%

3. Secondary Outcome

Title	Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)
Description	Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading).
Time Frame	100 days post transplant

Outcome Measure Data

Analysis Population Description

The number of intention-to-treat patients is 206. The incidence of aGVHD analysis is based on intention-to-treat (ITT) patients .

Arm/Group Title	rhGM-CSF	rhGM-CSF Plus rhG-CSF	rhG-CSF
Arm/Group Description	5-7μg/kg per day rhGM-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation.	rhGM-CSF and rhG-CSF both at 2-3μg/kg per day rhGM-CSF plus rhG-CSF: rhGM-CSF and rhG-CSF (both at 2-3μg/kg/d) subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation.	5-7μg/kg per day rhG-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation.
Measure Participants	68	69	69
Number (95% Confidence Interval) [percentage of partipants]	30.88	24.64	21.74

4. Primary Outcome

Title	Incidences of Invasive Fungal Diseases (IFD)
Description	The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation
Time Frame	100 day post transplant

Outcome Measure Data

Analysis Population Description

The number of intention-to-treat patients is 206. The incidence of invasive fungal infection analysis within 100 day is based on intention-to-treat (ITT)patients .

Arm/Group Title	rhGM-CSF Group	rhG-CSF+ rhGM-CSF	rhG-CSF Group
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Measure Participants	68	69	69
Number [percentage of partipants]	11.76	10.14	23.19

5. Secondary Outcome

Title	IFD Related Mortality
Description	IFD-related mortalities after a median follow-up of 600 days.
Time Frame	3-1099 days

Outcome Measure Data

Analysis Population Description

The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .

Arm/Group Title	rhGM-CSF Group	rhGM-CSF+ rhG-CSF Group	rhG-CSFgroup
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Measure Participants	68	69	69
Number (95% Confidence Interval) [percentage of participants]	1.47 2.2%	1.45 2.1%	11.59 16.8%

6. Secondary Outcome

Title	Relapse Related Mortality
Description	Relapse related mortality after a median follow-up of 600 days.
Time Frame	3～1099 days

Outcome Measure Data

Analysis Population Description

The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .

Arm/Group Title	rhGM-CSF Group	rhGM-CSF+ rhG-CSF Group	rhG-CSFgroup
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Measure Participants	68	69	69
Number [percentage of participants]	5.8 8.5%	8.7 12.6%	4.35 6.3%

7. Secondary Outcome

Title	Graft Versus Host Disease (aGVHD) Related Mortality
Description	Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days .
Time Frame	3-1099 days

Outcome Measure Data

Analysis Population Description

The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .

Arm/Group Title	rhGM-CSF Group	rhGM-CSF+ rhG-CSF Group	rhG-CSFgroup
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Measure Participants	68	69	69
Number [percentage of participants]	8.82 13%	4.35 6.3%	7.25 10.5%

8. Secondary Outcome

Title	Hemorrhage Related Mortality
Description	Hemorrhage related mortality after a median follow-up of 600 days
Time Frame	3-1099 days

Outcome Measure Data

Analysis Population Description

The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .

Arm/Group Title	rhGM-CSF Group	rhGM-CSF+ rhG-CSF Group	rhG-CSFgroup
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Measure Participants	68	69	69
Number [percentage of participants]	5.88 8.6%	1.45 2.1%	1.45 2.1%

9. Secondary Outcome

Title	Infection Related Mortality
Description	Infection related mortality after a median follow-up of 600 days.
Time Frame	3～1099 days)

Outcome Measure Data

Analysis Population Description

The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .

Arm/Group Title	rhGM-CSF Group	rhGM-CSF+ rhG-CSF Group	rhG-CSFgroup
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).	subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Measure Participants	68	69	69
Number [percentage of participants]	1.47 2.2%	5.8 8.4%	14.50 21%

Adverse Events

Time Frame	28 days post transplant
Arm/Group Title	rhGM-CSF Group		rhG-CSF + rhGM-CSF Group		rhG-CSF Group
Arm/Group Description	subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).		a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).		subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
All Cause Mortality
	rhGM-CSF Group		rhG-CSF + rhGM-CSF Group		rhG-CSF Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	rhGM-CSF Group		rhG-CSF + rhGM-CSF Group		rhG-CSF Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/69 (0%)		0/69 (0%)
Other (Not Including Serious) Adverse Events
	rhGM-CSF Group		rhG-CSF + rhGM-CSF Group		rhG-CSF Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	32/68 (47.1%)		31/69 (44.9%)		28/69 (40.6%)
Infections and infestations
fever	32/68 (47.1%)		31/69 (44.9%)		28/69 (40.6%)

Limitations/Caveats

The limitations of the current study included the lack of blinding and placebo group.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.