Trial Outcomes & Findings for A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer (NCT NCT02172911)

Last Updated: 2021-02-21

Results Overview

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Up to 36 weeks

Results posted on

2021-02-21

Participant Flow

Female participants with cervical cancer after chemoradiation for newly diagnosed disease or therapy for recurrent and/or persistent disease were enrolled in 2 study sites between 6th June 2014 to 7th September 2017.

Participant milestones

Participant milestones
Measure	Cohort I: INO-3112: Curative Intent Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Overall Study STARTED	7	3
Overall Study COMPLETED	6	1
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort I: INO-3112: Curative Intent Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Overall Study Serious Adverse Event	0	1
Overall Study Progression of Disease	0	1
Overall Study Loss of insurance coverage	1	0

Baseline Characteristics

A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Total n=10 Participants Total of all reporting groups
Age, Continuous	47.9 years STANDARD_DEVIATION 11.63 • n=5 Participants	41.7 years STANDARD_DEVIATION 14.64 • n=7 Participants	46.0 years STANDARD_DEVIATION 12.11 • n=5 Participants
Sex/Gender, Customized Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 weeks

Population: Safety population included all participants who received at least one dose of study treatment plus EP.

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)	100 percentage of participants Interval 59.0 to 100.0	100 percentage of participants Interval 29.2 to 100.0

PRIMARY outcome

Timeframe: Up to 36 weeks

Population: Safety population included all participants who received at least one dose of study treatment plus EP.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug. The severity of TEAEs was assessed by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE,v 4.03). TEAEs were graded on a 5-point scale where 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Potentially life-threatening and 5 = Death.

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Percentage of Participants With Grade 3 or Higher TEAEs Graded Per Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE, v 4.03) Anaemia	0 percentage of participants Interval 0.0 to 41.0	33.3 percentage of participants Interval 0.8 to 90.6
Percentage of Participants With Grade 3 or Higher TEAEs Graded Per Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE, v 4.03) Disseminated Intravascular Coagulation	0 percentage of participants Interval 0.0 to 41.0	33.3 percentage of participants Interval 0.8 to 90.6
Percentage of Participants With Grade 3 or Higher TEAEs Graded Per Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE, v 4.03) Abdominal Pain	14.3 percentage of participants Interval 0.4 to 57.9	0 percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Grade 3 or Higher TEAEs Graded Per Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE, v 4.03) Intestinal Perforation	0 percentage of participants Interval 0.0 to 41.0	33.3 percentage of participants Interval 0.8 to 90.6
Percentage of Participants With Grade 3 or Higher TEAEs Graded Per Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE, v 4.03) Pneumonia	14.3 percentage of participants Interval 0.4 to 57.9	0 percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Grade 3 or Higher TEAEs Graded Per Common Terminology Criteria for Adverse Events, Version 4.03 (CTCAE, v 4.03) Pathological Fracture	0 percentage of participants Interval 0.0 to 41.0	33.3 percentage of participants Interval 0.8 to 90.6

PRIMARY outcome

Timeframe: Up to 36 weeks

Population: Safety population included all participants who received at least one dose of study treatment plus EP.

Injection site reactions and administration site pain were evaluated starting 30 minutes following injection/EP. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' (Food and Drug Administration \[FDA\] Guidance for Industry, September 2007). Local reaction to the injectable product such as pain, tenderness, erythema/redness and induration/swelling were graded on a 4-point scale where: 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Potentially life-threatening.

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Percentage of Participants With Injection Site Reactions Injection Site Bruising	28.6 percentage of participants Interval 3.7 to 71.0	33.3 percentage of participants Interval 0.8 to 90.6
Percentage of Participants With Injection Site Reactions Injection Site Discolouration	0 percentage of participants Interval 0.0 to 41.0	33.3 percentage of participants Interval 0.8 to 90.6
Percentage of Participants With Injection Site Reactions Injection Site Erythema	14.3 percentage of participants Interval 0.4 to 57.9	0 percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Injection Site Reactions Injection Site Haemorrhage	14.3 percentage of participants Interval 0.4 to 57.9	0 percentage of participants Interval 0.0 to 70.8
Percentage of Participants With Injection Site Reactions Injection Site Pain	14.3 percentage of participants Interval 0.4 to 57.9	66.7 percentage of participants Interval 9.4 to 99.2
Percentage of Participants With Injection Site Reactions Injection Site Swelling	14.3 percentage of participants Interval 0.4 to 57.9	33.3 percentage of participants Interval 0.8 to 90.6

PRIMARY outcome

Timeframe: Up to 36 weeks

Population: The above-mentioned outcome could not be assessed as no data were captured that reflect the expected rates of acute gastrointestinal, genitourinary or other chemoradiation side effects, in order to compare those collected on this study with those from prior studies. While adverse event data related to study therapy were captured, these were not graded per acute radiation morbidity score because of the above-noted limitation. No comparison was thus possible that would reflect rates expected.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and Week 4, 8,12,16,24, 32 and 48

Population: Safety population included all participants who received at least one dose of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point.

Clinical laboratory parameters (hematology, serum chemistry, and creatine phosphokinase \[CPK\]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit.

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Hematocrit at the Indicated Time Points Baseline	30.87 percentage of blood Standard Deviation 3.118	35.03 percentage of blood Standard Deviation 5.016
Change From Baseline in Hematocrit at the Indicated Time Points Change from Baseline at Week 4	1.63 percentage of blood Standard Deviation 2.553	-2.10 percentage of blood Standard Deviation 2.800
Change From Baseline in Hematocrit at the Indicated Time Points Change from Baseline at Week 8	3.49 percentage of blood Standard Deviation 2.805	-5.90 percentage of blood Standard Deviation 6.505
Change From Baseline in Hematocrit at the Indicated Time Points Change from Baseline at Week 12	5.73 percentage of blood Standard Deviation 3.722	1.60 percentage of blood Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Hematocrit at the Indicated Time Points Change from Baseline at Week 16	5.97 percentage of blood Standard Deviation 3.288	2.10 percentage of blood Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Hematocrit at the Indicated Time Points Change from Baseline at Week 24	5.10 percentage of blood Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Hematocrit at the Indicated Time Points Change from Baseline at Week 32	4.80 percentage of blood Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Hematocrit at the Indicated Time Points Change from Baseline at Week 48	4.70 percentage of blood Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—

PRIMARY outcome

Timeframe: Baseline and Weeks 4, 8,12,16,24, 32 and 48

Population: The safety population included all participants who received at least one dose of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point.

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Hemoglobin at the Indicated Time Points Baseline	103.29 gram per liter (g/L) Standard Deviation 10.339	112.00 gram per liter (g/L) Standard Deviation 22.517
Change From Baseline in Hemoglobin at the Indicated Time Points Change from Baseline at Week 4	5.57 gram per liter (g/L) Standard Deviation 10.048	-7.00 gram per liter (g/L) Standard Deviation 9.165
Change From Baseline in Hemoglobin at the Indicated Time Points Change from Baseline at Week 8	11.14 gram per liter (g/L) Standard Deviation 12.402	-19.00 gram per liter (g/L) Standard Deviation 24.042
Change From Baseline in Hemoglobin at the Indicated Time Points Change from Baseline at Week 12	18.29 gram per liter (g/L) Standard Deviation 13.889	4.00 gram per liter (g/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Hemoglobin at the Indicated Time Points Change from Baseline at Week 16	20.29 gram per liter (g/L) Standard Deviation 11.086	8.00 gram per liter (g/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Hemoglobin at the Indicated Time Points Change from Baseline at Week 24	17.00 gram per liter (g/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Hemoglobin at the Indicated Time Points Change from Baseline at Week 32	8.00 gram per liter (g/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Hemoglobin at the Indicated Time Points Change from Baseline at Week 48	7.00 gram per liter (g/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—

PRIMARY outcome

Timeframe: Baseline and Weeks 4, 8,12,16,24, 32 and 48

Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase \[CPK\]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit. Hematology parameters analyzed for this outcome measure included: white blood cell (WBC) count, count of lymphocytes (L), monocytes (M) and neutrophils (N).

Outcome measures

PRIMARY outcome

Timeframe: Baseline and Weeks 4,8,12,16,24,32 and 48

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Platelet Count at the Indicated Time Points Platelet Count, Baseline	259.86 10^9 cells/liter (10^9/L) Standard Deviation 46.674	271.33 10^9 cells/liter (10^9/L) Standard Deviation 73.704
Change From Baseline in Platelet Count at the Indicated Time Points Platelet Count, Change from Baseline at Week 4	-45.29 10^9 cells/liter (10^9/L) Standard Deviation 55.479	26.00 10^9 cells/liter (10^9/L) Standard Deviation 48.754
Change From Baseline in Platelet Count at the Indicated Time Points Platelet Count, Change from Baseline at Week 8	-40.57 10^9 cells/liter (10^9/L) Standard Deviation 39.327	93.00 10^9 cells/liter (10^9/L) Standard Deviation 84.853
Change From Baseline in Platelet Count at the Indicated Time Points Platelet Count, Change from Baseline at Week 12	-41.00 10^9 cells/liter (10^9/L) Standard Deviation 61.563	37.00 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Platelet Count at the Indicated Time Points Platelet Count, Change from Baseline at Week 16	-32.86 10^9 cells/liter (10^9/L) Standard Deviation 49.911	2.00 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Platelet Count at the Indicated Time Points Platelet Count, Change From Baseline at Week 24	-17.00 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Platelet Count at the Indicated Time Points Platelet Count, Change from Baseline at Week 32	-68.00 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Platelet Count at the Indicated Time Points Platelet Count, Change from Baseline at Week 48	-73.00 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—

PRIMARY outcome

Timeframe: Baseline and Weeks 4 and 8

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points RBC Count, Baseline	3.34 10^12 cells/liter Standard Deviation 0.382	3.97 10^12 cells/liter Standard Deviation 0.586
Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points RBC Count, Change from Baseline at Week 4	0.07 10^12 cells/liter Standard Deviation 0.355	-0.23 10^12 cells/liter Standard Deviation 0.351
Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points RBC Count, Change from Baseline at Week 8	0.23 10^12 cells/liter Standard Deviation 0.386	-0.55 10^12 cells/liter Standard Deviation 0.778

PRIMARY outcome

Timeframe: Baseline and Weeks 4,8,12 and 16

Clinical laboratory parameters (hematology, serum chemistry, creatine phosphokinase \[CPK\]) were analyzed using descriptive statistics for actual values and changes from baseline to each study visit. Clinical chemistry parameter assessed in this outcome measure included alkaline phosphatase (ALP), alanine amino transferase (ALT) and aspartate amino transferase (AST).

Outcome measures

PRIMARY outcome

Timeframe: Baseline and Weeks 4,8,12 and 16

Outcome measures

PRIMARY outcome

Timeframe: Baseline and Weeks 4,8,12 and 16

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Albumin, Baseline	42.00 grams per liter (g/L) Standard Deviation 2.000	40.33 grams per liter (g/L) Standard Deviation 3.215
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Albumin, Change from Baseline at Week 4	-1.00 grams per liter (g/L) Standard Deviation 1.000	-1.00 grams per liter (g/L) Standard Deviation 1.000
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Albumin, Change from Baseline at Week 8	0.80 grams per liter (g/L) Standard Deviation 1.304	-2.50 grams per liter (g/L) Standard Deviation 3.536
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Albumin, Change from Baseline at Week 12	0.60 grams per liter (g/L) Standard Deviation 2.191	-2.00 grams per liter (g/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Albumin, Change from Baseline at Week 16	1.00 grams per liter (g/L) Standard Deviation 1.871	-1.00 grams per liter (g/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Total protein, Baseline	68.86 grams per liter (g/L) Standard Deviation 4.488	73.67 grams per liter (g/L) Standard Deviation 3.215
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Total protein, Change from Baseline at Week 4	1.20 grams per liter (g/L) Standard Deviation 2.168	-2.67 grams per liter (g/L) Standard Deviation 3.215
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Total protein, Change from Baseline at Week 8	2.80 grams per liter (g/L) Standard Deviation 4.087	-5.50 grams per liter (g/L) Standard Deviation 3.536
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Total protein, Change from Baseline at Week 12	2.20 grams per liter (g/L) Standard Deviation 5.805	-2.00 grams per liter (g/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Albumin and Total Protein at the Indicated Time Points Total protein, Change from Baseline at Week 16	3.20 grams per liter (g/L) Standard Deviation 5.357	-2.00 grams per liter (g/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.

PRIMARY outcome

Timeframe: Baseline and Week 16

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Creatine Phosphokinase (CPK) at the Indicated Time Points CPK, Baseline	46.9 units per liter (U/L) Standard Deviation 9.30	42.7 units per liter (U/L) Standard Deviation 15.50
Change From Baseline in Creatine Phosphokinase (CPK) at the Indicated Time Points CPK, Change from Baseline at Week 16	18.8 units per liter (U/L) Standard Deviation 15.80	30.0 units per liter (U/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.

PRIMARY outcome

Timeframe: Baseline and Weeks 4, 8,12 and 16

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Creatinine, Change from Baseline at Week 4	5.83 micromoles per liter (umol/L) Standard Deviation 7.543	2.95 micromoles per liter (umol/L) Standard Deviation 5.104
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Creatinine, Change from Baseline at Week 8	-1.59 micromoles per liter (umol/L) Standard Deviation 7.193	8.84 micromoles per liter (umol/L) Standard Deviation 12.502
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Creatinine, Change from Baseline at Week 12	6.01 micromoles per liter (umol/L) Standard Deviation 8.442	-17.68 micromoles per liter (umol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Total Bilirubin, Change from Baseline at Week 16	-0.00 micromoles per liter (umol/L) Standard Deviation 6.283	0.00 micromoles per liter (umol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Creatinine, Baseline	66.93 micromoles per liter (umol/L) Standard Deviation 16.817	70.72 micromoles per liter (umol/L) Standard Deviation 8.840
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Creatinine, Change from Baseline at Week 16	3.36 micromoles per liter (umol/L) Standard Deviation 8.015	-8.84 micromoles per liter (umol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Total Bilirubin, Baseline	7.82 micromoles per liter (umol/L) Standard Deviation 4.922	6.84 micromoles per liter (umol/L) Standard Deviation 4.524
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Total Bilirubin, Change from Baseline at Week 4	-1.71 micromoles per liter (umol/L) Standard Deviation 4.837	-1.71 micromoles per liter (umol/L) Standard Deviation 2.962
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Total Bilirubin, Change from Baseline at Week 8	-1.37 micromoles per liter (umol/L) Standard Deviation 4.083	-1.71 micromoles per liter (umol/L) Standard Deviation 4.837
Change From Baseline in Creatinine and Total Bilirubin at the Indicated Time Points Total Bilirubin, Change from Baseline at Week 12	-1.03 micromoles per liter (umol/L) Standard Deviation 5.353	0.00 micromoles per liter (umol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 6, 8, 10,12,14,16, 24, 32, 36, 40 and 48

Population: Modified intention-to-treat (mITT) population included all participants receiving at least one study treatment plus EP as assigned. Number analyzed is the number of participants with data available for analysis at a specified time-point.

Whole blood and serum samples to be tested for antibodies to the human papillomavirus (HPV) E6 and E7 proteins and/or T-lymphocytes producing interferon-gamma (IFN-γ) elicited by INO-3112 were assessed by enzyme-linked immunosorbent spot-forming assay (ELISpot).

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Baseline	8.6 SFU/10^6 PBMC Standard Deviation 6.03	6.7 SFU/10^6 PBMC Standard Deviation 2.89
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 2	—	1.7 SFU/10^6 PBMC Standard Deviation 2.35
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 4	26.4 SFU/10^6 PBMC Standard Deviation 29.84	2.5 SFU/10^6 PBMC Standard Deviation 3.54
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 6	20.0 SFU/10^6 PBMC Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	24.2 SFU/10^6 PBMC Standard Deviation 12.96
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 8	68.3 SFU/10^6 PBMC Standard Deviation 49.50	0.0 SFU/10^6 PBMC Standard Deviation 0.0
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 10	50.0 SFU/10^6 PBMC Standard Deviation 21.21	—
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 12	353.3 SFU/10^6 PBMC Standard Deviation 472.30	6.7 SFU/10^6 PBMC Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 14	27.5 SFU/10^6 PBMC Standard Deviation 8.24	—
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 16	310.3 SFU/10^6 PBMC Standard Deviation 460.00	53.3 SFU/10^6 PBMC Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 24	244.2 SFU/10^6 PBMC Standard Deviation 324.77	—
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 32	121.9 SFU/10^6 PBMC Standard Deviation 133.43	10.0 SFU/10^6 PBMC Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 36	6.7 SFU/10^6 PBMC Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 40	246.3 SFU/10^6 PBMC Standard Deviation 341.18	—
Change From Baseline in the Combined HPV-16 and HPV-18 E6 and E7 Antigen Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) Increase from Baseline at Week 48	248.8 SFU/10^6 PBMC Standard Deviation 351.79	—

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 6, 8, 10,12,14,16, 24, 32, 36, 40 and 48

Antigen-specific humoral responses against HPV E6 and E7 antigens induced by INO-3112 were measured using ELISA. Commercially available recombinant human HPV-16 and HPV-18 proteins were used to assess the induction of binding antibodies to each of the antigen components.

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16 ,Baseline	0.0 log titer Standard Deviation 0.00	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 2	2.5 log titer Standard Deviation 3.54	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 4	0.7 log titer Standard Deviation 1.60	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 6	2.5 log titer Standard Deviation 3.54	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 8	0.6 log titer Standard Deviation 1.48	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 10	0.0 log titer Standard Deviation 0.00	0.00 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 12	0.8 log titer Standard Deviation 1.75	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 14	2.0 log titer Standard Deviation 2.77	—
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 16	1.4 log titer Standard Deviation 2.44	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 24	3.0 log titer Standard Deviation 2.36	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 32	1.7 log titer Standard Deviation 2.59	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 36	0.0 log titer Standard Deviation 0.00	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 40	3.3 log titer Standard Deviation 2.89	—
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-16, Week 48	3.7 log titer Standard Deviation 3.26	—
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Baseline	0.0 log titer Standard Deviation 0.00	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 2	3.1 log titer Standard Deviation 4.32	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 4	0.7 log titer Standard Deviation 1.60	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 6	0.0 log titer Standard Deviation 0.00	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 8	0.6 log titer Standard Deviation 1.48	0.0 log titer Standard Deviation 0.00
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 10	1.3 log titer Standard Deviation 2.26	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 12	0.8 log titer Standard Deviation 1.75	6.1 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 14	0.0 log titer Standard Deviation 0.00	—
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 16	1.4 log titer Standard Deviation 2.53	6.1 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 24	0.7 log titer Standard Deviation 1.60	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 32	1.3 log titer Standard Deviation 2.02	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 36	1.5 log titer Standard Deviation 3.05	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 40	1.3 log titer Standard Deviation 2.26	—
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) HPV-18, Week 48	0.0 log titer Standard Deviation 0.00	—

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 32, 36, 40 and 48

Outcome measures

Outcome measures
Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 32	1.9 log titer Standard Deviation 3.05	8.3 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Baseline	0.0 log titer Standard Deviation 0.00	0.0 log titer Standard Deviation 0.00
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 2	0.0 log titer Standard Deviation 0.00	2.0 log titer Standard Deviation 2.77
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 4	0.7 log titer Standard Deviation 1.60	0.0 log titer Standard Deviation 0.00
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 6	0.0 log titer Standard Deviation 0.00	0.0 log titer Standard Deviation 0.00
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 8	0.8 log titer Standard Deviation 2.05	3.6 log titer Standard Deviation 5.10
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 10	3.3 log titer Standard Deviation 3.09	7.2 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 12	2.0 log titer Standard Deviation 2.85	7.2 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 14	3.1 log titer Standard Deviation 4.32	—
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 16	2.1 log titer Standard Deviation 2.75	7.2 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 24	2.7 log titer Standard Deviation 3.13	7.2 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 32	2.1 log titer Standard Deviation 2.38	7.2 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 36	1.6 log titer Standard Deviation 2.14	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 40	0.0 log titer Standard Deviation 0.00	—
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-16, Week 48	0.0 log titer Standard Deviation 0.00	—
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Baseline	0.0 log titer Standard Deviation 0.00	0.0 log titer Standard Deviation 0.00
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 2	1.7 log titer Standard Deviation 2.89	0.0 log titer Standard Deviation 0.00
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 4	0.8 log titer Standard Deviation 2.05	0.0 log titer Standard Deviation 0.00
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 6	5.0 log titer Standard Deviation 1.55	0.0 log titer Standard Deviation 0.00
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 8	2.4 log titer Standard Deviation 3.72	0.0 log titer Standard Deviation 0.00
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 10	1.3 log titer Standard Deviation 2.26	0.0 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 12	2.2 log titer Standard Deviation 3.26	7.2 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 14	2.0 log titer Standard Deviation 2.77	—
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 16	3.5 log titer Standard Deviation 3.56	7.2 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 24	1.2 log titer Standard Deviation 2.94	8.3 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 36	0.0 log titer Standard Deviation 0.00	8.3 log titer Standard Deviation NA Standard deviation could not be calculated due to an insufficient number of participants.
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 40	5.2 log titer Standard Deviation 4.51	—
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA HPV-18, Week 48	3.6 log titer Standard Deviation 5.10	—

Adverse Events

Cohort I: INO-3112: Curative Intent

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort II: INO-3112: Salvage Therapy

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort I: INO-3112: Curative Intent n=7 participants at risk Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 participants at risk Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Gastrointestinal disorders Abdominal Pain	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Intestinal Perforation	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Infections and infestations Endometritis	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Infections and infestations Pneumonia	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks

Other adverse events

Other adverse events
Measure	Cohort I: INO-3112: Curative Intent n=7 participants at risk Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 participants at risk Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • Up to 36 weeks	66.7% 2/3 • Up to 36 weeks
Blood and lymphatic system disorders Neutropenia	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Cardiac disorders Tachycardia	28.6% 2/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Ear and labyrinth disorders Ear Pain	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Abdominal Pain	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Abdominal Pain Lower	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Abdominal Pain Upper	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Constipation	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Defaecation Urgency	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Diarrhoea	42.9% 3/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Dry Mouth	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Gastrointestinal Motility Disorder	14.3% 1/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Gastrointestinal disorders Gastrooesophageal Reflux Disease	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Haemorrhoids	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Hiatus Hernia	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Large Intestine Polyp	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Nausea	42.9% 3/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Gastrointestinal disorders Rectal Ulcer	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Toothache	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Gastrointestinal disorders Vomiting	14.3% 1/7 • Up to 36 weeks	66.7% 2/3 • Up to 36 weeks
General disorders Chest Pain	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
General disorders Fatigue	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
General disorders Injection Site Bruising	28.6% 2/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
General disorders Injection Site Discolouration	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
General disorders Injection Site Erythema	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
General disorders Injection Site Haemorrhage	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
General disorders Injection Site Pain	14.3% 1/7 • Up to 36 weeks	66.7% 2/3 • Up to 36 weeks
General disorders Injection Site Swelling	14.3% 1/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
General disorders Malaise	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
General disorders Peripheral Swelling	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
General disorders Pyrexia	28.6% 2/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Hepatobiliary disorders Cholecystitis	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Hepatobiliary disorders Hepatic Steatosis	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Infections and infestations Influenza	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Infections and infestations Pyometra	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Infections and infestations Sinusitis	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Infections and infestations Urinary Tract Infection	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Injury, poisoning and procedural complications Ligament Sprain	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Injury, poisoning and procedural complications Radiation Proctopathy	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Investigations Weight Decreased	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Investigations White Blood Cell Count Decreased	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Metabolism and nutrition disorders Decreased Appetite	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Metabolism and nutrition disorders Hyperglycaemia	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Musculoskeletal and connective tissue disorders Arthralgia	28.6% 2/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Musculoskeletal and connective tissue disorders Back Pain	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Musculoskeletal and connective tissue disorders Bone Pain	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Musculoskeletal and connective tissue disorders Joint Swelling	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Musculoskeletal and connective tissue disorders Pain In Extremity	28.6% 2/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Musculoskeletal and connective tissue disorders Pain In Jaw	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Nervous system disorders Dizziness	14.3% 1/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Nervous system disorders Dysgeusia	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Nervous system disorders Headache	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Nervous system disorders Neuropathy Peripheral	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Nervous system disorders Paraesthesia	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Nervous system disorders Parosmia	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Psychiatric disorders Anxiety	14.3% 1/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Psychiatric disorders Insomnia	28.6% 2/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Renal and urinary disorders Hydronephrosis	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Renal and urinary disorders Nocturia	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Renal and urinary disorders Pollakiuria	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Renal and urinary disorders Proteinuria	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Renal and urinary disorders Urge Incontinence	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Renal and urinary disorders Urinary Incontinence	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Reproductive system and breast disorders Coital Bleeding	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Reproductive system and breast disorders Dyspareunia	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Reproductive system and breast disorders Uterine Pain	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Reproductive system and breast disorders Uterine Prolapse	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Reproductive system and breast disorders Vaginal Haemorrhage	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Reproductive system and breast disorders Vaginal Stricture	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Reproductive system and breast disorders Vulvovaginal Pain	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 1/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Skin and subcutaneous tissue disorders Excessive Granulation Tissue	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Skin and subcutaneous tissue disorders Rash Maculo-Papular	14.3% 1/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks
Vascular disorders Deep Vein Thrombosis	0.00% 0/7 • Up to 36 weeks	33.3% 1/3 • Up to 36 weeks
Vascular disorders Hot Flush	28.6% 2/7 • Up to 36 weeks	0.00% 0/3 • Up to 36 weeks

Additional Information

Study Director

Inovio Pharmaceuticals

Phone: 267-440-4237

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points N, Baseline	2.60 10^9 cells/liter (10^9/L) Standard Deviation 2.129	4.03 10^9 cells/liter (10^9/L) Standard Deviation 0.551
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points L, Baseline	0.93 10^9 cells/liter (10^9/L) Standard Deviation 0.522	0.70 10^9 cells/liter (10^9/L) Standard Deviation 0.400
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points L,Change from Baseline at Week 4	-0.11 10^9 cells/liter (10^9/L) Standard Deviation 0.261	0.00 10^9 cells/liter (10^9/L) Standard Deviation 0.200
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points L,Change from Baseline at Week 8	-0.04 10^9 cells/liter (10^9/L) Standard Deviation 0.251	-0.10 10^9 cells/liter (10^9/L) Standard Deviation 0.141
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points L, Change from Baseline at Week 12	-0.10 10^9 cells/liter (10^9/L) Standard Deviation 0.283	-0.20 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points L, Change from Baseline at Week 16	0.01 10^9 cells/liter (10^9/L) Standard Deviation 0.254	-0.20 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points L, Change From Baseline at Week 24	0.20 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points L, Change from Baseline at Week 32	-0.50 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points L, Change from Baseline at Week 48	-0.40 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points M, Baseline	0.39 10^9 cells/liter (10^9/L) Standard Deviation 0.121	0.30 10^9 cells/liter (10^9/L) Standard Deviation 0.100
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points M,Change from Baseline at Week 4	-0.06 10^9 cells/liter (10^9/L) Standard Deviation 0.172	0.07 10^9 cells/liter (10^9/L) Standard Deviation 0.153
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points M,Change from Baseline at Week 8	-0.03 10^9 cells/liter (10^9/L) Standard Deviation 0.138	0.05 10^9 cells/liter (10^9/L) Standard Deviation 0.212
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points M,Change from Baseline at Week 12	-0.03 10^9 cells/liter (10^9/L) Standard Deviation 0.138	0.10 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points M,Change from Baseline at Week 16	-0.07 10^9 cells/liter (10^9/L) Standard Deviation 0.160	0.10 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points M,Change from Baseline at Week 24	0.00 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points M,Change from Baseline at Week 32	-0.40 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points M,Change from Baseline at Week 48	-0.20 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points N,Change from Baseline at Week 4	0.43 10^9 cells/liter (10^9/L) Standard Deviation 0.964	0.37 10^9 cells/liter (10^9/L) Standard Deviation 1.266
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points N,Change from Baseline at Week 8	0.09 10^9 cells/liter (10^9/L) Standard Deviation 1.188	0.85 10^9 cells/liter (10^9/L) Standard Deviation 0.212
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points N,Change from Baseline at Week 12	-0.03 10^9 cells/liter (10^9/L) Standard Deviation 0.138	0.10 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points N,Change from Baseline at Week 16	-0.07 10^9 cells/liter (10^9/L) Standard Deviation 0.160	0.10 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points N,Change from Baseline at Week 24	0.00 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points N,Change from Baseline at Week 32	-0.40 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points N,Change from Baseline at Week 48	-0.20 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points WBC, Baseline	4.20 10^9 cells/liter (10^9/L) Standard Deviation 2.239	5.30 10^9 cells/liter (10^9/L) Standard Deviation 0.721
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points WBC, Change from Baseline at Week 4	0.33 10^9 cells/liter (10^9/L) Standard Deviation 0.966	0.40 10^9 cells/liter (10^9/L) Standard Deviation 1.114
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points WBC, Change from Baseline at Week 8	0.27 10^9 cells/liter (10^9/L) Standard Deviation 1.237	0.85 10^9 cells/liter (10^9/L) Standard Deviation 0.212
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points WBC, Change from Baseline at Week 12	0.01 10^9 cells/liter (10^9/L) Standard Deviation 1.771	0.40 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points WBC, Change from Baseline at Week 16	0.66 10^9 cells/liter (10^9/L) Standard Deviation 1.279	1.40 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points WBC, Change from Baseline at Week 24	0.90 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points WBC, Change from Baseline at Week 32	-0.40 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Lymphocytes, Monocytes, Neutrophils and White Blood Cell (WBC) Count at the Indicated Time Points WBC, Change from Baseline at Week 48	-0.30 10^9 cells/liter (10^9/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—

Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALP, Baseline	73.29 units per liter (U/L) Standard Deviation 26.606	81.33 units per liter (U/L) Standard Deviation 10.017
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALP, Change from Baseline at Week 4	0.20 units per liter (U/L) Standard Deviation 13.989	14.67 units per liter (U/L) Standard Deviation 21.779
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALP, Change from Baseline at Week 8	3.00 units per liter (U/L) Standard Deviation 20.273	54.00 units per liter (U/L) Standard Deviation 65.054
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALP, Change from Baseline at Week 12	4.00 units per liter (U/L) Standard Deviation 26.448	0.00 units per liter (U/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALP, Change from Baseline at Week 16	8.60 units per liter (U/L) Standard Deviation 22.233	1.00 units per liter (U/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALT, Baseline	20.14 units per liter (U/L) Standard Deviation 6.793	13.00 units per liter (U/L) Standard Deviation 9.849
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALT, Change from Baseline at Week 4	4.60 units per liter (U/L) Standard Deviation 13.353	-3.67 units per liter (U/L) Standard Deviation 11.590
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALT, Change from Baseline at Week 8	-5.00 units per liter (U/L) Standard Deviation 4.950	-4.50 units per liter (U/L) Standard Deviation 14.849
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALT, Change from Baseline at Week 12	-1.60 units per liter (U/L) Standard Deviation 6.229	-14.00 units per liter (U/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points ALT, Change from Baseline at Week 16	-2.20 units per liter (U/L) Standard Deviation 3.768	-15.00 units per liter (U/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points AST, Baseline	22.71 units per liter (U/L) Standard Deviation 6.945	17.00 units per liter (U/L) Standard Deviation 7.937
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points AST, Change from Baseline at Week 4	3.20 units per liter (U/L) Standard Deviation 8.526	-5.67 units per liter (U/L) Standard Deviation 11.547
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points AST, Change from Baseline at Week 8	-3.80 units per liter (U/L) Standard Deviation 6.340	-5.00 units per liter (U/L) Standard Deviation 14.142
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points AST, Change from Baseline at Week 12	1.20 units per liter (U/L) Standard Deviation 13.461	-15.00 units per liter (U/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at the Indicated Time Points AST, Change from Baseline at Week 16	-2.80 units per liter (U/L) Standard Deviation 4.658	-16.00 units per liter (U/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.

Measure	Cohort I: INO-3112: Curative Intent n=7 Participants Cohort I included participants with biopsy-proven, stage IB-IVB inoperable, newly diagnosed invasive cervical carcinoma associated with HPV-16 and/or HPV-18 treated with standard chemoradiation therapy with curative intent. Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.	Cohort II: INO-3112: Salvage Therapy n=3 Participants Cohort II included participants with persistent and/or recurrent cervical carcinoma associated with HPV-16 and/or HPV-18 who had been treated with salvage therapy (chemotherapy and/or radiation therapy). Participants received a 4-dose series of 1.1 mL IM injection of INO-3112 followed immediately by EP with CELLECTRA™-5P.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Bicarbonate, Baseline	25.00 millimole per liter (mmol/L) Standard Deviation 1.633	24.33 millimole per liter (mmol/L) Standard Deviation 2.082
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Bicarbonate, Change from Baseline at Week 4	0.00 millimole per liter (mmol/L) Standard Deviation 1.000	3.33 millimole per liter (mmol/L) Standard Deviation 0.577
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Bicarbonate, Change from Baseline at Week 8	-0.60 millimole per liter (mmol/L) Standard Deviation 2.074	0.00 millimole per liter (mmol/L) Standard Deviation 2.828
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Bicarbonate, Change from Baseline at Week 12	-1.40 millimole per liter (mmol/L) Standard Deviation 0.548	2.00 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Bicarbonate, Change from Baseline at Week 16	-0.40 millimole per liter (mmol/L) Standard Deviation 1.140	4.00 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Glucose, Baseline	6.90 millimole per liter (mmol/L) Standard Deviation 2.994	5.25 millimole per liter (mmol/L) Standard Deviation 1.042
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Glucose, Change from Baseline at Week 4	-0.60 millimole per liter (mmol/L) Standard Deviation 0.736	1.18 millimole per liter (mmol/L) Standard Deviation 0.946
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Glucose, Change from Baseline at Week 8	-0.57 millimole per liter (mmol/L) Standard Deviation 0.839	2.69 millimole per liter (mmol/L) Standard Deviation 2.237
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Glucose, Change from Baseline at Week 12	-0.78 millimole per liter (mmol/L) Standard Deviation 0.755	0.39 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Glucose, Change from Baseline at Week 16	-0.46 millimole per liter (mmol/L) Standard Deviation 0.308	-1.44 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points BUN, Baseline	4.18 millimole per liter (mmol/L) Standard Deviation 1.897	4.17 millimole per liter (mmol/L) Standard Deviation 1.687
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points BUN, Change from Baseline at Week 4	0.86 millimole per liter (mmol/L) Standard Deviation 1.485	-1.07 millimole per liter (mmol/L) Standard Deviation 1.071
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points BUN, Change from Baseline at Week 8	0.50 millimole per liter (mmol/L) Standard Deviation 1.568	0.18 millimole per liter (mmol/L) Standard Deviation 0.757
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points BUN, Change from Baseline at Week 12	1.87 millimole per liter (mmol/L) Standard Deviation 3.085	-1.79 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points BUN, Change from Baseline at Week 16	1.29 millimole per liter (mmol/L) Standard Deviation 1.686	-0.71 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Ca, Baseline	2.33 millimole per liter (mmol/L) Standard Deviation 0.089	2.37 millimole per liter (mmol/L) Standard Deviation 0.014
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Ca, Change from Baseline at Week 4	0.05 millimole per liter (mmol/L) Standard Deviation 0.077	-0.06 millimole per liter (mmol/L) Standard Deviation 0.104
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Ca, Change from Baseline at Week 8	0.02 millimole per liter (mmol/L) Standard Deviation 0.045	-0.16 millimole per liter (mmol/L) Standard Deviation 0.088
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Ca, Change from Baseline at Week 12	0.01 millimole per liter (mmol/L) Standard Deviation 0.086	-0.08 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Ca, Change from Baseline at Week 16	0.04 millimole per liter (mmol/L) Standard Deviation 0.121	-0.15 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Cl, Baseline	91.57 millimole per liter (mmol/L) Standard Deviation 28.757	100.00 millimole per liter (mmol/L) Standard Deviation 3.464
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Cl, Change from Baseline at Week 4	15.40 millimole per liter (mmol/L) Standard Deviation 34.530	-1.00 millimole per liter (mmol/L) Standard Deviation 2.646
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Cl, Change from Baseline at Week 8	14.60 millimole per liter (mmol/L) Standard Deviation 35.494	-1.00 millimole per liter (mmol/L) Standard Deviation 1.414
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Cl, Change from Baseline at Week 12	14.00 millimole per liter (mmol/L) Standard Deviation 34.785	1.00 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Cl, Change from Baseline at Week 16	14.40 millimole per liter (mmol/L) Standard Deviation 33.923	0.00 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points K, Baseline	4.20 millimole per liter (mmol/L) Standard Deviation 0.383	4.37 millimole per liter (mmol/L) Standard Deviation 0.252
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points K, Change from Baseline at Week 4	-0.16 millimole per liter (mmol/L) Standard Deviation 0.503	-0.43 millimole per liter (mmol/L) Standard Deviation 1.305
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points K, Change from Baseline at Week 8	-0.06 millimole per liter (mmol/L) Standard Deviation 0.391	-0.65 millimole per liter (mmol/L) Standard Deviation 1.061
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points K, Change from Baseline at Week 12	-0.02 millimole per liter (mmol/L) Standard Deviation 0.466	-0.70 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points K, Change from Baseline at Week 16	-0.14 millimole per liter (mmol/L) Standard Deviation 0.365	-1.00 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Mg, Baseline	0.41 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.	—
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Na, Baseline	141.29 millimole per liter (mmol/L) Standard Deviation 3.147	138.67 millimole per liter (mmol/L) Standard Deviation 1.528
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Na, Change from Baseline at Week 4	0.00 millimole per liter (mmol/L) Standard Deviation 2.915	1.67 millimole per liter (mmol/L) Standard Deviation 4.726
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Na, Change from Baseline at Week 8	-0.20 millimole per liter (mmol/L) Standard Deviation 1.924	-0.50 millimole per liter (mmol/L) Standard Deviation 3.536
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Na, Change from Baseline at Week 12	-1.20 millimole per liter (mmol/L) Standard Deviation 2.280	4.00 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.
Change From Baseline in Bicarbonate, Glucose, Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Potassium (K), Magnesium (Mg) and Sodium (Na) at the Indicated Time Points Na, Change from Baseline at Week 16	-0.60 millimole per liter (mmol/L) Standard Deviation 1.517	3.00 millimole per liter (mmol/L) Standard Deviation NA Standard deviation could not be calculated due to insufficient number of participants.