Trial Outcomes & Findings for A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC (NCT NCT02905591)
NCT ID: NCT02905591
Last Updated: 2026-07-31
Results Overview
The proportion of participants with progressive disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at the completion of radiation and chemotherapy.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
3 to 4 weeks after last radiation treatment
Results posted on
2026-07-31
Participant Flow
Participant milestones
| Measure |
ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
ChemoRT + Ascorbate
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC
Baseline characteristics by cohort
| Measure |
ChemoRT + Ascorbate
n=43 Participants
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
Radiation Therapy: Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days
Paclitaxel: Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered
* the dose is 45 mg/m2 (standard dose)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standardized dose reductions are used
Carboplatin: Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.
* Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standard dose reductions are used
Ascorbic Acid: Administered intravenously
* 75 grams per infusion; each infusion is about 2 hours
* 3 infusion per calendar week
* The infusion is actively running for at least 20 minutes when radiation begins
* May be given while chemotherapy is delayed due to low counts
* Dose reductions are not used
* Given for 6 to 7 weeks, depending on when radiation starts
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=9 Participants
|
|
Age, Continuous
|
66 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 3 to 4 weeks after last radiation treatmentPopulation: Study participants who completed radiation and chemotherapy and determined evaluable
The proportion of participants with progressive disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at the completion of radiation and chemotherapy.
Outcome measures
| Measure |
ChemoRT + Ascorbate
n=39 Participants
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
|
|---|---|
|
Progression Rate at the Completion of Radiation and Chemotherapy
|
6 Participants
|
SECONDARY outcome
Timeframe: Every six months for up to 20 years post-treatmentFrom radiation day 1 to documented disease progression as described by RECIST criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every six months for up to 20 years post-treatmentTime, measured in days, it takes for disease to progress, where disease progression is defined by the RECIST criteria (v1.1). Timeframe is from radiation day 1 to date of disease progression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every three months for up to 20 years post-treatmentTime, measured in months, from start of radiation to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatmentCategorize and quantify adverse events using the Common Terminology Criteria for Adverse Events (CTCAE, v 4) as follows: * Through radiation, weekly assessment of adverse events * Consolidation chemotherapy, assessment day 1 of each cycle * Post-treatment, every 6 months through 2 years post-therapy
Outcome measures
Outcome data not reported
Adverse Events
ChemoRT + Ascorbate
Serious events: 23 serious events
Other events: 42 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
ChemoRT + Ascorbate
n=43 participants at risk
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
Radiation Therapy: Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days
Paclitaxel: Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered
* the dose is 45 mg/m2 (standard dose)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standardized dose reductions are used
Carboplatin: Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.
* Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standard dose reductions are used
Ascorbic Acid: Administered intravenously
* 75 grams per infusion; each infusion is about 2 hours
* 3 infusion per calendar week
* The infusion is actively running for at least 20 minutes when radiation begins
* May be given while chemotherapy is delayed due to low counts
* Dose reductions are not used
* Given for 6 to 7 weeks, depending on when radiation starts
|
|---|---|
|
General disorders
Fever
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Cardiac disorders
Acute coronary syndrome
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Cardiac disorders
Atrial fibrillation
|
7.0%
3/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Esophagitis
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Fatigue
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Infusion related reaction
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Lung infection
|
11.6%
5/43 • Number of events 5 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Sepsis
|
9.3%
4/43 • Number of events 4 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Urinary tract infection
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
9.3%
4/43 • Number of events 4 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
Other adverse events
| Measure |
ChemoRT + Ascorbate
n=43 participants at risk
Radiation therapy, intravenous paclitaxel, intravenous carboplatin, intravenous ascorbic acid (pharmacological ascorbate)
Radiation Therapy: Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days
Paclitaxel: Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered
* the dose is 45 mg/m2 (standard dose)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standardized dose reductions are used
Carboplatin: Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.
* Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard)
* Administered weekly
* 6 to 7 weeks of therapy, depending on when radiation starts
* Standard dose reductions are used
Ascorbic Acid: Administered intravenously
* 75 grams per infusion; each infusion is about 2 hours
* 3 infusion per calendar week
* The infusion is actively running for at least 20 minutes when radiation begins
* May be given while chemotherapy is delayed due to low counts
* Dose reductions are not used
* Given for 6 to 7 weeks, depending on when radiation starts
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Blood and lymphatic system disorders
Anemia
|
76.7%
33/43 • Number of events 68 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Cardiac disorders
Acute coronary syndrome
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Cardiac disorders
Atrial fibrillation
|
11.6%
5/43 • Number of events 8 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Cardiac disorders
Chest pain - cardiac
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Cardiac disorders
Palpitations
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Cardiac disorders
Sinus tachycardia
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Ear and labyrinth disorders
Ear pain
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Endocrine disorders
Hypoparathyroidism
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Endocrine disorders
Hypothyroidism
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Eye disorders
Eye pain
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Bloating
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Constipation
|
60.5%
26/43 • Number of events 43 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Diarrhea
|
46.5%
20/43 • Number of events 34 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Dry mouth
|
20.9%
9/43 • Number of events 33 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Dysphagia
|
27.9%
12/43 • Number of events 15 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Esophagitis
|
62.8%
27/43 • Number of events 39 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
18.6%
8/43 • Number of events 8 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
18.6%
8/43 • Number of events 10 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Nausea
|
67.4%
29/43 • Number of events 50 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Oral pain
|
4.7%
2/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Toothache
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Gastrointestinal disorders
Vomiting
|
25.6%
11/43 • Number of events 21 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Chills
|
69.8%
30/43 • Number of events 40 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Edema limbs
|
18.6%
8/43 • Number of events 12 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Edema trunk
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Fatigue
|
76.7%
33/43 • Number of events 61 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Fever
|
14.0%
6/43 • Number of events 7 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
14.0%
6/43 • Number of events 6 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Infusion related reaction
|
14.0%
6/43 • Number of events 9 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Injection site reaction
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Localized edema
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Non-cardiac chest pain
|
30.2%
13/43 • Number of events 16 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
General disorders
Pain
|
30.2%
13/43 • Number of events 23 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Immune system disorders
Allergic reaction
|
11.6%
5/43 • Number of events 7 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Bladder infection
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Bronchial infection
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
23.3%
10/43 • Number of events 19 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Lung infection
|
11.6%
5/43 • Number of events 5 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Rash pustular
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Sepsis
|
7.0%
3/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Urinary tract infection
|
9.3%
4/43 • Number of events 6 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Infections and infestations
Vaginal infection
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
48.8%
21/43 • Number of events 29 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Injury, poisoning and procedural complications
Fall
|
7.0%
3/43 • Number of events 5 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
4.7%
2/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Alanine aminotransferase increased
|
18.6%
8/43 • Number of events 13 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Alkaline phosphatase increased
|
7.0%
3/43 • Number of events 10 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
3/43 • Number of events 7 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Blood bilirubin increased
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Cardiac troponin I increased
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Creatinine increased
|
4.7%
2/43 • Number of events 8 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Investigations - Other, specify
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Lymphocyte count decreased
|
95.3%
41/43 • Number of events 140 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Neutrophil count decreased
|
65.1%
28/43 • Number of events 60 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Platelet count decreased
|
34.9%
15/43 • Number of events 22 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Weight gain
|
2.3%
1/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
Weight loss
|
18.6%
8/43 • Number of events 21 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Investigations
White blood cell decreased
|
76.7%
33/43 • Number of events 87 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
60.5%
26/43 • Number of events 40 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
9.3%
4/43 • Number of events 4 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.6%
11/43 • Number of events 20 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.7%
2/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
41.9%
18/43 • Number of events 30 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
32.6%
14/43 • Number of events 27 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
34.9%
15/43 • Number of events 26 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.3%
4/43 • Number of events 4 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.6%
14/43 • Number of events 25 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.7%
2/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
4.7%
2/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
4/43 • Number of events 5 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.0%
3/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
7.0%
3/43 • Number of events 4 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.0%
3/43 • Number of events 11 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Nervous system disorders
Akathisia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Nervous system disorders
Dizziness
|
30.2%
13/43 • Number of events 28 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Nervous system disorders
Dysgeusia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Nervous system disorders
Headache
|
30.2%
13/43 • Number of events 17 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Nervous system disorders
Paresthesia
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.6%
11/43 • Number of events 14 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Nervous system disorders
Presyncope
|
4.7%
2/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Nervous system disorders
Tremor
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Psychiatric disorders
Insomnia
|
7.0%
3/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
7.0%
3/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Renal and urinary disorders
Urinary frequency
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
39.5%
17/43 • Number of events 26 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
46.5%
20/43 • Number of events 34 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.6%
5/43 • Number of events 9 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.0%
3/43 • Number of events 3 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
30.2%
13/43 • Number of events 14 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
37.2%
16/43 • Number of events 16 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
1/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
27.9%
12/43 • Number of events 17 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.0%
3/43 • Number of events 5 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.0%
3/43 • Number of events 4 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.3%
7/43 • Number of events 8 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.3%
4/43 • Number of events 4 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.0%
6/43 • Number of events 10 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
9.3%
4/43 • Number of events 5 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Social circumstances
Social circumstances - Other, specify
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Vascular disorders
Flushing
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Vascular disorders
Hematoma
|
4.7%
2/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Vascular disorders
Hot flashes
|
2.3%
1/43 • Number of events 1 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Vascular disorders
Hypertension
|
2.3%
1/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Vascular disorders
Hypotension
|
18.6%
8/43 • Number of events 12 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Vascular disorders
Thromboembolic event
|
2.3%
1/43 • Number of events 2 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
|
Vascular disorders
Vascular disorders - Other, specify
|
74.4%
32/43 • Number of events 234 • Adverse events were collected weekly for the first 7 weeks, then monthly for 3 months, then every 6 months through 2 years post-treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place