Trial Outcomes & Findings for BrUOG 355: Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer (NCT NCT03527264)

NCT ID: NCT03527264

Last Updated: 2025-04-04

Results Overview

Number of patients that are alive without disease progression at time of analysis.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

From start of study treatment through date of study completion, an average of 2 years.

Results posted on

2025-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1A Nivolumab during Chemo/RT with whole pelvic RT Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.	Cohort 1B Nivolumab during Chemo/RT with extended field Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.
Overall Study STARTED	3	1
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BrUOG 355: Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1A n=3 Participants Nivolumab during Chemo/RT with whole pelvic RT Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.	Cohort 1B n=1 Participants Nivolumab during Chemo/RT with extended field Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.	Cohort 2 Chemoradiation followed by Nivolumab Maintenance Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years	Cohort 3 Nivolumab during chemoradiation and then as maintenance Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation. Nivolumab maintenance: Nivolumab 480 mg IV every 4 weeks for 2 years	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	—	—	2 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	—	—	2 Participants n=21 Participants
Age, Continuous	66 years n=5 Participants	54 years n=7 Participants	—	—	63 years n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	—	—	4 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	—	—	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	—	—	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	—	—	3 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	—	—	1 Participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	1 participants n=7 Participants	—	—	4 participants n=21 Participants

PRIMARY outcome

Timeframe: From start of study treatment through date of study completion, an average of 2 years.

Number of patients that are alive without disease progression at time of analysis.

Outcome measures

Outcome measures
Measure	Cohort 1A n=3 Participants Nivolumab during Chemo/RT with whole pelvic RT Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.	Cohort 1B n=1 Participants Nivolumab during Chemo/RT with extended field Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.
Progression Free Survival	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From start of study treatment through date of study completion, an average of 2 years.

Population: Only 1 patient on cohort 1A had recurrence within 3 years of study entry.

Determination of the site of recurrence, loco-regional versus distant

Outcome measures

Outcome measures
Measure	Cohort 1A n=1 Participants Nivolumab during Chemo/RT with whole pelvic RT Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.	Cohort 1B Nivolumab during Chemo/RT with extended field Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.
Recurrence Patterns Loco-regional	1 Participants	0 Participants
Recurrence Patterns Distant	0 Participants	0 Participants

Adverse Events

Cohort 1A

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 1B

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1A n=3 participants at risk Nivolumab during Chemo/RT with whole pelvic RT Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.	Cohort 1B n=1 participants at risk Nivolumab during Chemo/RT with extended field Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.
Gastrointestinal disorders Nausea	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Gastrointestinal disorders Vomiting	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
General disorders Fatigue	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
General disorders Generalized muscle weakness	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Infections and infestations Sepsis	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Psychiatric disorders Suicidal ideation	0.00% 0/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Vascular disorders Hypotension	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.

Other adverse events

Additional Information

Don S. Dizon, MD

Brown Oncology Research Group

Phone: 4018633000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1A n=3 participants at risk Nivolumab during Chemo/RT with whole pelvic RT Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.	Cohort 1B n=1 participants at risk Nivolumab during Chemo/RT with extended field Nivolumab induction: 2 doses Nivolumab 240mg IV Cisplatin: 40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy. Radiation: Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field Nivolumab with chemoradiation: Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.
Blood and lymphatic system disorders Anemia	100.0% 3/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
General disorders Fatigue	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Metabolism and nutrition disorders Hyponatremia	66.7% 2/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Gastrointestinal disorders Nausea	66.7% 2/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Gastrointestinal disorders Vomiting	66.7% 2/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Psychiatric disorders Dizziness	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Weight loss	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
General disorders Chills	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Metabolism and nutrition disorders Dehydration	66.7% 2/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Psychiatric disorders Anxiety	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Lipase increased	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Lymphocyte count decreased	100.0% 3/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Metabolism and nutrition disorders Hypokalemia	66.7% 2/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations White blood cell count decreased	100.0% 3/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Neutrophil count decreased	66.7% 2/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Reproductive system and breast disorders Pelvic pain	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Vascular disorders Hypotension	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Psychiatric disorders Insomnia	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Gastrointestinal disorders Diarrhea	100.0% 3/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Immune system disorders Allergic reaction	0.00% 0/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Alanine aminotransferase increased	0.00% 0/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Hypoalbuminemia	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Platelet count decreased	66.7% 2/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Metabolism and nutrition disorders Hypomagnesemia	100.0% 3/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	100.0% 1/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Infections and infestations Upper respiratory infection	66.7% 2/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Gastrointestinal disorders Constipation	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Gastrointestinal disorders GERD	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Serum amylase increased	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Serum creatinine increased	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
General disorders Fever	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
General disorders Cough	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Respiratory, thoracic and mediastinal disorders Wheezing	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.
Investigations Hypocalcemia	33.3% 1/3 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.	0.00% 0/1 • All adverse events were reported from the time a signed and dated ICF is obtained through study treatment completion, an average of 6 months.