Trial Outcomes & Findings for Pharmacological Ascorbate for Lung Cancer (NCT NCT02420314)
NCT ID: NCT02420314
Last Updated: 2024-08-20
Results Overview
From cycle 1, day 1, to documented disease progression in CT imaging as described by RECIST criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
every 2 months for up to 5 years post treatment
Results posted on
2024-08-20
Participant Flow
Enrollment was between April 2015 through November 2020
Participant milestones
| Measure |
Ascorbate, Paclitaxel, Carboplatin
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
Paclitaxel: - Administered intravenously (IV)
* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Carboplatin: - Administered intravenously (IV)
* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Ascorbic Acid: - Administered intravenously (IV)
* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Ascorbate, Paclitaxel, Carboplatin
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
Paclitaxel: - Administered intravenously (IV)
* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Carboplatin: - Administered intravenously (IV)
* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Ascorbic Acid: - Administered intravenously (IV)
* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Pharmacological Ascorbate for Lung Cancer
Baseline characteristics by cohort
| Measure |
Ascorbate, Paclitaxel, Carboplatin
n=38 Participants
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
Paclitaxel: - Administered intravenously (IV)
* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Carboplatin: - Administered intravenously (IV)
* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Ascorbic Acid: - Administered intravenously (IV)
* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 2 months for up to 5 years post treatmentFrom cycle 1, day 1, to documented disease progression in CT imaging as described by RECIST criteria
Outcome measures
| Measure |
Ascorbate, Paclitaxel, Carboplatin
n=38 Participants
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
Paclitaxel: - Administered intravenously (IV)
* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Carboplatin: - Administered intravenously (IV)
* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Ascorbic Acid: - Administered intravenously (IV)
* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts
|
|---|---|
|
Tumor Response
confirmed partial response
|
13 Participants
|
|
Tumor Response
stable disease
|
19 Participants
|
|
Tumor Response
progressive disease
|
5 Participants
|
|
Tumor Response
unevaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: every 2 months for up to 5 years post treatmentThe time (in months) it takes for disease to progress as defined by RECIST criteria. Timeframe will be from cycle 1, day 1 to date of progression.
Outcome measures
| Measure |
Ascorbate, Paclitaxel, Carboplatin
n=38 Participants
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
Paclitaxel: - Administered intravenously (IV)
* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Carboplatin: - Administered intravenously (IV)
* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Ascorbic Acid: - Administered intravenously (IV)
* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts
|
|---|---|
|
Progression Free Survival (PFS)
|
5.7 months
Interval 4.3 to 7.0
|
SECONDARY outcome
Timeframe: every 2 months for up to 5 years post treatmentTime, measured in months, from cycle 1 day 1 until date of death from any cause
Outcome measures
| Measure |
Ascorbate, Paclitaxel, Carboplatin
n=38 Participants
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
Paclitaxel: - Administered intravenously (IV)
* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Carboplatin: - Administered intravenously (IV)
* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Ascorbic Acid: - Administered intravenously (IV)
* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts
|
|---|---|
|
Overall Survival (OS)
|
12.8 months
Interval 8.7 to 21.7
|
Adverse Events
Ascorbate, Paclitaxel, Carboplatin
Serious events: 18 serious events
Other events: 40 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Ascorbate, Paclitaxel, Carboplatin
n=40 participants at risk
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
Paclitaxel: - Administered intravenously (IV)
* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Carboplatin: - Administered intravenously (IV)
* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Ascorbic Acid: - Administered intravenously (IV)
* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts
|
|---|---|
|
Cardiac disorders
Cardiac disorder, other
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
urinary tract infection
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Renal and urinary disorders
urinary retention
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
lung infection
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
thromboembolic event
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Hepatobiliary disorders
hepatobiliary disorder, other
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Death nos
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Fever
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
Other adverse events
| Measure |
Ascorbate, Paclitaxel, Carboplatin
n=40 participants at risk
Paclitaxel, administered once per cycle (3 weeks) Carboplatin, administered once per cycle (3 weeks) Pharmacological ascorbate (ascorbic acid) infusions, 2 times per week for 3 weeks
Paclitaxel: - Administered intravenously (IV)
* Prescribed at 200 mg/m2 (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Carboplatin: - Administered intravenously (IV)
* Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
* Given once every 21 days (i.e., one cycle)
* Up to 4 cycles are administered depending on disease response
Ascorbic Acid: - Administered intravenously (IV)
* 75g per infusion
* Two infusions per week
* 1 cycle is 3 weeks
* given up to 4 cycles
* may be given while chemotherapy if delayed due to low counts
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Akathisia
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Alanine aminotransferase increased
|
17.5%
7/40 • Number of events 7 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
5/40 • Number of events 5 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Immune system disorders
Allergic reaction
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
6/40 • Number of events 6 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Blood and lymphatic system disorders
Anemia
|
57.5%
23/40 • Number of events 23 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Anorexia
|
37.5%
15/40 • Number of events 15 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
anxiety
|
27.5%
11/40 • Number of events 11 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
40.0%
16/40 • Number of events 16 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
8/40 • Number of events 8 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Reproductive system and breast disorders
benign prostate hypertrophy
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
bicarbonate decreased
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Eye disorders
Blurred vision
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
body pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Bronchial infection
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Burning at IV site
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Chills
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Cognitive disturbance
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Eye disorders
Conjunctivitis
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Constipation
|
32.5%
13/40 • Number of events 13 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
6/40 • Number of events 6 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Creatinine increased
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
32.5%
13/40 • Number of events 13 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Dizziness
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
drowsiness
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Dry lips
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Dry mouth
|
40.0%
16/40 • Number of events 16 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Dysgeusia
|
15.0%
6/40 • Number of events 6 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
8/40 • Number of events 8 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
early satiety
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Edema face
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Edema limbs
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
elevated iron
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Enterocolitis infectious
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Fatigue
|
72.5%
29/40 • Number of events 29 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Fever
|
20.0%
8/40 • Number of events 8 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Flank pain - right side
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
Flushing
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Gait disturbance
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
GGT increased
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Headache
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
Hematoma
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Renal and urinary disorders
Hematuria
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Hepatitis viral
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Hot flash
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
Hypertension
|
37.5%
15/40 • Number of events 15 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Endocrine disorders
Hyperthyroidism
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
8/40 • Number of events 8 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
10/40 • Number of events 10 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.5%
11/40 • Number of events 11 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
Hypotension
|
15.0%
6/40 • Number of events 6 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Infection - toenail
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Infusion related reaction
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Infusion site extravasation
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Injection site reaction
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Psychiatric disorders
Insomnia
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Itchy ears
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
IV infiltration
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
IV site pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
knee pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
left big toe pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
left hip and low back
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
lip bite
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Lung infection
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Lymphocyte count decreased
|
32.5%
13/40 • Number of events 13 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Immune system disorders
Maculopapular rash
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
metatarsal fracture
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Mucosal infection
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Multi-organ failure
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
mural thrombus
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb right side
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.5%
11/40 • Number of events 11 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Nausea
|
65.0%
26/40 • Number of events 26 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Neutrophil count decreased
|
37.5%
15/40 • Number of events 15 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
night sweats
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Cardiac disorders
Non-specific T wave abnormality
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Oral Candidiasis
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
5/40 • Number of events 5 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - bilateral hand
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - right arm
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
pain left big toe
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
pain over 3 metatarsal LT foot
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Cardiac disorders
paroxysmal atrial fibrillation
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
Peripheral edema, right arm
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
60.0%
24/40 • Number of events 24 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Platelet count decreased
|
40.0%
16/40 • Number of events 16 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
General disorders
port site pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
RLL pulmonary embolus
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.0%
2/40 • Number of events 2 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Sinus pain
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Skin infection
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Somnolence
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
Superior vena cava syndrome
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
Syncope
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Vascular disorders
Thromboembolic event
|
10.0%
4/40 • Number of events 4 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Nervous system disorders
tingling left hand
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Ear and labyrinth disorders
Tinnitus
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Tooth infection
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Renal and urinary disorders
Urinary retention
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Infections and infestations
Urinary tract infection
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
32.5%
13/40 • Number of events 13 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Eye disorders
Watering eyes
|
2.5%
1/40 • Number of events 1 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
Weight loss
|
7.5%
3/40 • Number of events 3 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
|
Investigations
White blood cell decreased
|
25.0%
10/40 • Number of events 10 • Deaths were assessed for up to 5 years post-treatment. Adverse events were assessed for up to 6 months post-enrollment (minimum of 21 days after the final ascorbate infusion if early completion).
Adverse events are defined by federal code and consistent with the definitions provided by clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place