Trial Outcomes & Findings for Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101) (NCT NCT00075803)
NCT ID: NCT00075803
Last Updated: 2023-01-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
180 days
Results posted on
2023-01-04
Participant Flow
Participants were enrolled from November 2003 through September 2006
Participant milestones
| Measure |
Fluconazole
fluconazole prophylaxis
|
Voriconazole
voriconazole prophylaxis
|
|---|---|---|
|
Overall Study
STARTED
|
295
|
305
|
|
Overall Study
COMPLETED
|
295
|
305
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)
Baseline characteristics by cohort
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
43 years
n=5 Participants
|
43 years
n=7 Participants
|
43 years
n=5 Participants
|
|
Age, Customized
<18 years
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Age, Customized
≥18 years
|
271 participants
n=5 Participants
|
278 participants
n=7 Participants
|
549 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
265 participants
n=5 Participants
|
276 participants
n=7 Participants
|
541 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Graft Source
Bone marrow
|
109 participants
n=5 Participants
|
106 participants
n=7 Participants
|
215 participants
n=5 Participants
|
|
Graft Source
Peripheral blood
|
186 participants
n=5 Participants
|
197 participants
n=7 Participants
|
383 participants
n=5 Participants
|
|
Graft Source
Cord blood
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Primary Disease
Acute myeloid leukemia
|
101 participants
n=5 Participants
|
133 participants
n=7 Participants
|
234 participants
n=5 Participants
|
|
Primary Disease
Acute lymphoblastic leukemia
|
64 participants
n=5 Participants
|
58 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Primary Disease
Chronic myelogenous leukemia
|
60 participants
n=5 Participants
|
43 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Primary Disease
Myelodysplastic syndrome
|
49 participants
n=5 Participants
|
49 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Primary Disease
Non-Hodgkin lymphoma
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Match
6 of 6
|
282 participants
n=5 Participants
|
293 participants
n=7 Participants
|
575 participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Match
5 of 6
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Karnofsky/Lansky Performance Status
90% - 100%
|
249 participants
n=5 Participants
|
268 participants
n=7 Participants
|
517 participants
n=5 Participants
|
|
Karnofsky/Lansky Performance Status
< 90%
|
46 participants
n=5 Participants
|
37 participants
n=7 Participants
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: All randomized patients were included in the analysis
Outcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Fungal-free Survival (Percentage of Participants Alive and Free From Proven, Probable, or Presumptive Invasive Fungal Infection) at 180 Days Post-transplant
|
74.9 percentage of patients
Interval 69.6 to 79.5
|
78.2 percentage of patients
Interval 73.1 to 82.4
|
SECONDARY outcome
Timeframe: 1 yearIncidence of proven, probably, or presumptive IFI
Outcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Frequency of Invasive Fungal Infections (IFI)
|
13.7 percentage of patients
Interval 9.8 to 17.6
|
12.7 percentage of patients
Interval 9.0 to 16.4
|
SECONDARY outcome
Timeframe: 100, 180, and 365 daysOutcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Percentage of Patients With Invasive Fungal Infection at 100, 180, and 365 Days
100 days
|
9.5 percentage of patients
Interval 6.2 to 12.8
|
5.6 percentage of patients
Interval 3.1 to 8.1
|
|
Percentage of Patients With Invasive Fungal Infection at 100, 180, and 365 Days
180 days
|
11.2 percentage of patients
Interval 7.7 to 14.7
|
7.3 percentage of patients
Interval 4.4 to 10.2
|
|
Percentage of Patients With Invasive Fungal Infection at 100, 180, and 365 Days
365 days
|
13.7 percentage of patients
Interval 9.8 to 17.6
|
12.7 percentage of patients
Interval 9.0 to 16.4
|
SECONDARY outcome
Timeframe: 100, 180, and 365 daysOutcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Overall Survival
100 days
|
85.4 percentage of patients
Interval 80.9 to 89.0
|
90.1 percentage of patients
Interval 86.2 to 93.0
|
|
Overall Survival
180 days
|
80.0 percentage of patients
Interval 75.0 to 84.1
|
81.2 percentage of patients
Interval 76.3 to 85.1
|
|
Overall Survival
365 days
|
70.2 percentage of patients
Interval 64.6 to 75.1
|
67.8 percentage of patients
Interval 62.1 to 72.8
|
SECONDARY outcome
Timeframe: 100, 180, and 365 daysOutcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Relapse Free Survival
100 days
|
83.1 percentage of patients
Interval 78.3 to 86.9
|
86.1 percentage of patients
Interval 81.7 to 89.6
|
|
Relapse Free Survival
180 days
|
74.9 percentage of patients
Interval 69.6 to 79.5
|
73.9 percentage of patients
Interval 68.5 to 78.5
|
|
Relapse Free Survival
365 days
|
63.3 percentage of patients
Interval 57.4 to 68.6
|
61.2 percentage of patients
Interval 55.5 to 66.5
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Frequency of Use of Amphotericin B or Caspofungin
|
30.2 percentage of patients
Interval 24.9 to 35.5
|
24.1 percentage of patients
Interval 19.2 to 29.0
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Duration of Use of Amphotericin B or Caspofungin
Number of days on study drug
|
91 days
Interval 27.0 to 100.0
|
96 days
Interval 34.0 to 101.0
|
|
Duration of Use of Amphotericin B or Caspofungin
Start day of empiric antifungal therapy
|
16 days
Interval 10.0 to 33.0
|
12 days
Interval 8.0 to 39.0
|
|
Duration of Use of Amphotericin B or Caspofungin
Days of empiric antifungal therapy
|
7 days
Interval 4.0 to 17.0
|
7 days
Interval 5.0 to 15.0
|
SECONDARY outcome
Timeframe: 100 and 365 daysOutcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Time to and Severity of Acute and Chronic Graft vs Host Disease (GVHD)
Acute GVHD grade III-IV at day 100
|
42 participants
|
27 participants
|
|
Time to and Severity of Acute and Chronic Graft vs Host Disease (GVHD)
Chronic GVHD at 1 year
|
138 participants
|
137 participants
|
|
Time to and Severity of Acute and Chronic Graft vs Host Disease (GVHD)
Acute GVHD grade II-IV at day 100
|
132 participants
|
116 participants
|
SECONDARY outcome
Timeframe: 1 yearAlthough there were 82 Galactomannan (GM) positives, 4 were excluded due to piperacillin/tazobactam administration, without other documentation of IFI, and were deemed false positives.
Outcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Utility of Galactomannan Assay in Diagnosis of Aspergillus and Response to Therapy
GM+
|
43 participants
|
35 participants
|
|
Utility of Galactomannan Assay in Diagnosis of Aspergillus and Response to Therapy
GM-
|
252 participants
|
270 participants
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 180 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 42Outcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Failure to Engraft
|
11 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Fluconazole
n=295 Participants
fluconazole prophylaxis
|
Voriconazole
n=305 Participants
voriconazole prophylaxis
|
|---|---|---|
|
Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days
IFI before engraftment
|
12 participants
|
8 participants
|
|
Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days
IFI after relapse/progression
|
2 participants
|
8 participants
|
|
Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days
IFI who had failure to engraft
|
2 participants
|
1 participants
|
|
Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days
IFI after aGVHD (grades II-IV)
|
11 participants
|
14 participants
|
|
Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days
IFI while on study drug (up to day 100)
|
19 participants
|
10 participants
|
|
Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days
IFI after premature withdrawal of study drug
|
11 participants
|
16 participants
|
|
Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days
IFI after start other prophylaxis (not study drug)
|
8 participants
|
11 participants
|
|
Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days
IFI after empiric therapy
|
13 participants
|
12 participants
|
Adverse Events
Fluconazole
Serious events: 78 serious events
Other events: 196 other events
Deaths: 0 deaths
Voriconazole
Serious events: 73 serious events
Other events: 199 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluconazole
n=295 participants at risk
fluconazole prophylaxis
|
Voriconazole
n=305 participants at risk
voriconazole prophylaxis
|
|---|---|---|
|
Cardiac disorders
Cardiovascular arrhythmia
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.34%
1/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Vascular disorders
Pulmoary embolus
|
1.0%
3/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Congenital, familial and genetic disorders
troponin level grade 4
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Vascular disorders
hypotension
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Nervous system disorders
Guillian-Barre syndrome
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PTLD
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Renal and urinary disorders
acute renal failure
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Nervous system disorders
confusion
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Nervous system disorders
seizure
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.68%
2/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.3%
45/295 • 1 year
|
12.8%
39/305 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.34%
1/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Cardiac disorders
AV Block - third Degree
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Psychiatric disorders
Acute Mental Status Change
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Renal and urinary disorders
Urinary Frequency/urgency
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Investigations
Elevated Magnesium
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Nervous system disorders
Cerebrovascular Ischemia
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Nervous system disorders
Sagittal Sinus Thrombosis
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
General disorders
Death at home, unexpected
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain, Site Right Kidney
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Surgical and medical procedures
Appendectomy
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Eye disorders
Photopsia
|
0.00%
0/295 • 1 year
|
0.66%
2/305 • 1 year
|
|
Nervous system disorders
Somnolence
|
2.0%
6/295 • 1 year
|
1.6%
5/305 • 1 year
|
|
Psychiatric disorders
Psychosis
|
0.68%
2/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Nervous system disorders
Seizures
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Nervous system disorders
Confusion
|
1.4%
4/295 • 1 year
|
1.6%
5/305 • 1 year
|
|
Cardiac disorders
EKG Abnormality
|
2.7%
8/295 • 1 year
|
1.6%
5/305 • 1 year
|
|
Cardiac disorders
Arrythmia
|
3.4%
10/295 • 1 year
|
2.3%
7/305 • 1 year
|
|
Vascular disorders
Hypotension
|
5.4%
16/295 • 1 year
|
5.2%
16/305 • 1 year
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
1.0%
3/295 • 1 year
|
0.66%
2/305 • 1 year
|
|
Renal and urinary disorders
Renal Failure
|
3.4%
10/295 • 1 year
|
2.3%
7/305 • 1 year
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
0.00%
0/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
5.8%
17/295 • 1 year
|
5.6%
17/305 • 1 year
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
3.7%
11/295 • 1 year
|
5.2%
16/305 • 1 year
|
|
Vascular disorders
Hemorrhage
|
4.1%
12/295 • 1 year
|
3.0%
9/305 • 1 year
|
|
Blood and lymphatic system disorders
HUS/TTP/thrombotic microangiopathy
|
2.0%
6/295 • 1 year
|
1.3%
4/305 • 1 year
|
|
Vascular disorders
Vascular Leak Syndrome
|
2.4%
7/295 • 1 year
|
2.3%
7/305 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.6%
43/295 • 1 year
|
11.8%
36/305 • 1 year
|
|
General disorders
Allergic Reaction / Hypersensitivity
|
0.00%
0/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
General disorders
Fever
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
General disorders
Rigors/Chills
|
0.00%
0/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/295 • 1 year
|
0.00%
0/305 • 1 year
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/295 • 1 year
|
0.33%
1/305 • 1 year
|
Other adverse events
| Measure |
Fluconazole
n=295 participants at risk
fluconazole prophylaxis
|
Voriconazole
n=305 participants at risk
voriconazole prophylaxis
|
|---|---|---|
|
Eye disorders
Photopsia
|
6.1%
18/295 • 1 year
|
6.2%
19/305 • 1 year
|
|
Nervous system disorders
Somnolence
|
8.1%
24/295 • 1 year
|
9.8%
30/305 • 1 year
|
|
Psychiatric disorders
Psychosis
|
6.8%
20/295 • 1 year
|
8.9%
27/305 • 1 year
|
|
Nervous system disorders
Seizures
|
3.1%
9/295 • 1 year
|
2.0%
6/305 • 1 year
|
|
Nervous system disorders
Confusion
|
19.3%
57/295 • 1 year
|
16.1%
49/305 • 1 year
|
|
Cardiac disorders
EKG Abnormality
|
10.2%
30/295 • 1 year
|
9.8%
30/305 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
1.4%
4/295 • 1 year
|
2.3%
7/305 • 1 year
|
|
Vascular disorders
Hypotension
|
8.1%
24/295 • 1 year
|
3.0%
9/305 • 1 year
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
2.7%
8/295 • 1 year
|
0.33%
1/305 • 1 year
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
6.4%
19/295 • 1 year
|
3.3%
10/305 • 1 year
|
|
Hepatobiliary disorders
Hepatic Dysfunction
|
29.5%
87/295 • 1 year
|
33.1%
101/305 • 1 year
|
|
Hepatobiliary disorders
Liver Abnormality
|
5.8%
17/295 • 1 year
|
3.9%
12/305 • 1 year
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
22.4%
66/295 • 1 year
|
20.3%
62/305 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.8%
20/295 • 1 year
|
5.9%
18/305 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.5%
34/295 • 1 year
|
7.5%
23/305 • 1 year
|
|
General disorders
Allergic Reaction / Hypersensitivity
|
1.7%
5/295 • 1 year
|
1.6%
5/305 • 1 year
|
|
Vascular disorders
Hypertension
|
2.4%
7/295 • 1 year
|
1.3%
4/305 • 1 year
|
|
General disorders
Fever
|
9.2%
27/295 • 1 year
|
5.9%
18/305 • 1 year
|
|
General disorders
Rigors, chills
|
4.7%
14/295 • 1 year
|
0.98%
3/305 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
8.5%
25/295 • 1 year
|
5.6%
17/305 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
15/295 • 1 year
|
2.6%
8/305 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place