Trial Outcomes & Findings for P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (NCT NCT03113487)
NCT ID: NCT03113487
Last Updated: 2025-07-20
Results Overview
Clinical response was assessed using the modified irRECIST criteria. Complete Response (CR) - Disappearance of all lesions, 2 consecutive observations, ≥ 4 wks apart; Partial Response (PR) - ≥50% decrease in tumor burden from baseline, 2 consecutive observations, ≥ 4 wks apart. Response = CR+PR.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2025-07-20
Participant Flow
Participant milestones
| Measure |
p53MVA and Pembrolizumab
Patients received 5.6 × 10\^8 pfu of p53MVA delivered as an intramuscular injection into the upper arm over the deltoid muscle followed by pembrolizumab 200 mg intravenously 30 minutes after vaccination. Both agents were given on day 1 of a 21-day cycle for three cycles, followed by single agent pembrolizumab 200 mg every 3 weeks up to 35 cycles (2 years total).
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
p53MVA and Pembrolizumab
Patients received 5.6 × 10\^8 pfu of p53MVA delivered as an intramuscular injection into the upper arm over the deltoid muscle followed by pembrolizumab 200 mg intravenously 30 minutes after vaccination. Both agents were given on day 1 of a 21-day cycle for three cycles, followed by single agent pembrolizumab 200 mg every 3 weeks up to 35 cycles (2 years total).
|
|---|---|
|
Overall Study
After cycle 1 sepsis was deemed present at baseline, so the patient was ineligible
|
1
|
Baseline Characteristics
P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
p53MVA and Pembrolizumab
n=28 Participants
Patients received 5.6 × 10\^8 pfu of p53MVA delivered as an intramuscular injection into the upper arm over the deltoid muscle followed by pembrolizumab 200 mg intravenously 30 minutes after vaccination. Both agents were given on day 1 of a 21-day cycle for three cycles, followed by single agent pembrolizumab 200 mg every 3 weeks up to 35 cycles (2 years total).
|
|---|---|
|
Age, Continuous
|
64 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian, Non-Hispanic
|
15 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0: Fully active, with no performance restrictions
|
13 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1: Restricted in strenuous activity, but fully ambulatory and able to carry out light work
|
15 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsClinical response was assessed using the modified irRECIST criteria. Complete Response (CR) - Disappearance of all lesions, 2 consecutive observations, ≥ 4 wks apart; Partial Response (PR) - ≥50% decrease in tumor burden from baseline, 2 consecutive observations, ≥ 4 wks apart. Response = CR+PR.
Outcome measures
| Measure |
p53MVA and Pembrolizumab
n=28 Participants
Patients received 5.6 × 10\^8 pfu of p53MVA delivered as an intramuscular injection into the upper arm over the deltoid muscle followed by pembrolizumab 200 mg intravenously 30 minutes after vaccination. Both agents were given on day 1 of a 21-day cycle for three cycles, followed by single agent pembrolizumab 200 mg every 3 weeks up to 35 cycles (2 years total).
|
|---|---|
|
Number of Patients Achieving Complete or Partial Response
|
3 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed up to 24 monthsEstimated using the product-limit method of Kaplan and Meier. From initial treatment until progression or death. Progression is defined using Immune-related response criteria (irRECIST, irRC), as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 wks apart.
Outcome measures
| Measure |
p53MVA and Pembrolizumab
n=28 Participants
Patients received 5.6 × 10\^8 pfu of p53MVA delivered as an intramuscular injection into the upper arm over the deltoid muscle followed by pembrolizumab 200 mg intravenously 30 minutes after vaccination. Both agents were given on day 1 of a 21-day cycle for three cycles, followed by single agent pembrolizumab 200 mg every 3 weeks up to 35 cycles (2 years total).
|
|---|---|
|
Progression-free Survival
|
1.8 Months
Interval 1.7 to 3.8
|
SECONDARY outcome
Timeframe: From start of the treatment until death, assessed up to 24 monthsEstimated using the product-limit method of Kaplan and Meier. From the time of initial treatment until death from any cause.
Outcome measures
| Measure |
p53MVA and Pembrolizumab
n=28 Participants
Patients received 5.6 × 10\^8 pfu of p53MVA delivered as an intramuscular injection into the upper arm over the deltoid muscle followed by pembrolizumab 200 mg intravenously 30 minutes after vaccination. Both agents were given on day 1 of a 21-day cycle for three cycles, followed by single agent pembrolizumab 200 mg every 3 weeks up to 35 cycles (2 years total).
|
|---|---|
|
Overall Survival
|
15.1 Months
Interval 9.4 to 30.4
|
SECONDARY outcome
Timeframe: Up to 24 monthsClinical response was assessed using the modified irRECIST criteria. Complete Response (CR) - Disappearance of all lesions, 2 consecutive observations, ≥ 4 wks apart; Partial Response (PR) - ≥50% decrease in tumor burden from baseline, 2 consecutive observations, ≥ 4 wks apart; Stable Disease (SD) - 50% decrease in tumor burden from baseline cannot be established, nor 25% increase compared with nadir. Clinical benefit = CR+PR+ stable disease \[SD\] \> 6 months.
Outcome measures
| Measure |
p53MVA and Pembrolizumab
n=28 Participants
Patients received 5.6 × 10\^8 pfu of p53MVA delivered as an intramuscular injection into the upper arm over the deltoid muscle followed by pembrolizumab 200 mg intravenously 30 minutes after vaccination. Both agents were given on day 1 of a 21-day cycle for three cycles, followed by single agent pembrolizumab 200 mg every 3 weeks up to 35 cycles (2 years total).
|
|---|---|
|
Clinical Benefit Rate
|
21.4 percentage of participants
|
Adverse Events
p53MVA and Pembrolizumab
Serious events: 5 serious events
Other events: 27 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
p53MVA and Pembrolizumab
n=28 participants at risk
Patients received 5.6 × 10\^8 pfu of p53MVA delivered as an intramuscular injection into the upper arm over the deltoid muscle followed by pembrolizumab 200 mg intravenously 30 minutes after vaccination. Both agents were given on day 1 of a 21-day cycle for three cycles, followed by single agent pembrolizumab 200 mg every 3 weeks up to 35 cycles (2 years total).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
p53MVA and Pembrolizumab
n=28 participants at risk
Patients received 5.6 × 10\^8 pfu of p53MVA delivered as an intramuscular injection into the upper arm over the deltoid muscle followed by pembrolizumab 200 mg intravenously 30 minutes after vaccination. Both agents were given on day 1 of a 21-day cycle for three cycles, followed by single agent pembrolizumab 200 mg every 3 weeks up to 35 cycles (2 years total).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
35.7%
10/28 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Heart failure
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
17.9%
5/28 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
21.4%
6/28 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
4/28 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Conjunctivitis
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
17.9%
5/28 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
35.7%
10/28 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Ascites
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Bowel Urgency
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Colitis
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
8/28 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
8/28 • Number of events 19 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
10.7%
3/28 • Number of events 29 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
2/28 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
1/28 • Number of events 19 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
12/28 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal pain
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
9/28 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
gum tenderness
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
17.9%
5/28 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
14.3%
4/28 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
53.6%
15/28 • Number of events 63 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
32.1%
9/28 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu like symptoms
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Injection site reaction
|
96.4%
27/28 • Number of events 61 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Localized edema
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Malaise
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Non-cardiac chest pain
|
7.1%
2/28 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Allergic reaction
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
Autoimmune disorder
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Urinary tract infection
|
10.7%
3/28 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Wound infection
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplastin time pr
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
17.9%
5/28 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
17.9%
5/28 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
4/28 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Blood bilirubin increased
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
17.9%
5/28 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
10.7%
3/28 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
7.1%
2/28 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
White blood cell decreased
|
7.1%
2/28 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
4/28 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
2/28 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
14.3%
4/28 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.1%
9/28 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.4%
6/28 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
8/28 • Number of events 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.1%
9/28 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.3%
4/28 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
3/28 • Number of events 38 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
6/28 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
4/28 • Number of events 39 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
2/28 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
4/28 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
hand cramping
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
2/28 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Presyncope
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
7.1%
2/28 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
10.7%
3/28 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hematuria
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
4/28 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
8/28 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.7%
3/28 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
21.4%
6/28 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
1/28 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
7.1%
2/28 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.6%
1/28 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.6%
1/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
10.7%
3/28 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
7/28 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.9%
5/28 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.7%
3/28 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
3.6%
1/28 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.6%
1/28 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
psoriasis
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
3.6%
1/28 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
25.0%
7/28 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
10.7%
3/28 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment. Adverse events occurred over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place